PALACOS R+ G SING DOSE 40 GR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for PALACOS R+ G SING DOSE 40 GR manufactured by Zimmer, Inc..

Event Text Entries

[176048185] Infected total joint in (b)(6) 2018. Spacer and then replaced in (b)(6) 2018. Left hip prosthesis stem broke in (b)(6) 2019. Arthritis left hip, hip(left) replacement 2009, infection left hip (b)(6) 2018. Left spur with 3mm, replaced again; (b)(6) 2018 broke and replaced again in (b)(6) 2019. I am writing with some concerns in reference t total hip replacements i myself have had several done with some complications that are questionable. I have enclosed a description of what has happened to me and would like it reviewed with some consideration. I originally had a total left hip replacement back in 2009. I had no problems and felt terrific. No problems with the recovery time and was able to go back to work without any extra delay, just the 9 - 10 weeks time off. As time went on then about 5 years later, i had to have a total right hip replacement. Once again this went off without any difficulties, no additional time off work needed, returned without any restrictions. I was going along well then in (b)(6) 2018, i started having some severe lower back pain that had left the doctors perplexed at first. They were treating me for lumbago or possibly sciatic pain. All attempts to treat the issue went unfounded. I continued to have pain and in trying to reduce the swelling in the back, i was sent to a chiropractor for treatment. While there the left hip dislocated, no direct pressure, no falls, no trauma, nothing that could pin- point why this occurred. I was taken to surgery to have it reduced and during that time labs were drawn and found to have some elevation in values. The following morning once again the hip dislocated and back to surgery i went. At this time the joint was aspirated and found to be infected. They did this due to the elevated lab values from the night prior. After the infection was found i was sent on to an orthopedic specialist and i was found to have a total joint full of infection. I had to have the joint removed, antibiotic permeated spacer placed and no weight bearing for 8 weeks, before being able to have the total joint replaced then in (b)(6) 2018. Some how the spacer bent during the bedrest, no weight bearing time period. The physician stated that he had not seen that happen into many instances. I lost a large amount of work time due to this situation, almost lost my job. I returned to work in (b)(6) 2018. Upon returning to work all was going well as expected from the (b)(6) 2018 until (b)(6) 2019 the left hip replacement dislocated and needed to be reduced 5 times. This was a painful and stressful time that was unexpected. Then in (b)(6) 2019 the femoral stem component of the prosthesis was found to be broken clear in two. Of course, once again surgery, another new total left hip replacement done. I spent 8-9 weeks no weight bearing, and the healing is progressing well without any problems. I have obtained all the information that i could on the equipment used in all the surgeries and would like to have this reviewed to see if there were any possible recalls. I believe the hardware that was used in the second total left hip replacement after the infection was defective. I went through a great deal of pain and anguish and all the doctors say is it was malfunctioning hardware. I do not believe that this is acceptable and i feel that the items need to be reviewed that are enclosed. Please investigate the hardware to see if any recalls or anything were applicable. I certainly would hate to have others go through what i went through to no accord. If there is any compensation to be had}t would be much appreciated , due to increased pain and discomfort, the cost of multiple surgeries, need to stay in rehabilitation facility, physical therapy and finally loss of income. I have been dealing with this for far too long and would appreciate some consideration. Thank you so much for your time and help with this experience. Like i said please review and i would like to hear back from this letter. I enclosed the surgery report information with the lot numbers and dates of everything, plus i enclosed a copy of the x-ray of the fractured femoral stern.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092337
MDR Report Key9601550
Date Received2020-01-16
Date of Report2020-01-09
Date of Event2019-07-19
Date Added to Maude2020-01-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePALACOS R+ G SING DOSE 40 GR
Generic NameBONE CEMENT ANTIBIOTICS
Product CodeMBB
Date Received2020-01-16
Lot Number877734705
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerZIMMER, INC.

Device Sequence Number: 2

Brand NameWIRE LUQUE LOOPED CLSD
Generic NameCERCLAGE FIXATION
Product CodeJDQ
Date Received2020-01-16
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerZIMMER INC.

Device Sequence Number: 3

Brand NameIMPL HIP ACET SHELL R3 MULTI HOLE 54MM
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Product CodeLPH
Date Received2020-01-16
Lot Number17CW07943
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 4

Brand NameIMPL HIP COVER THR HOLEMED DEMAND
Generic NameHIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED METAL POLYMER
Product CodeLPH
Date Received2020-01-16
Lot Number17KM18134D
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 5

Brand NameSCREW HIP CANC SPHR HEAD 6.5X20MM
Generic NameSCREW, FIXATION, BONE
Product CodeHWC
Date Received2020-01-16
Lot Number17JB00471
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No5
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 6

Brand NameSCREW HIP CANC SPHR HEAD 6.5X25MM
Generic NameSCREW FIXATION, BONE
Product CodeHWC
Date Received2020-01-16
Lot Number17KB01526
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No6
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 7

Brand NameSCREW REFLECTION SPHERICAL HEAD 15MM
Generic NamePROSTHESIS,HIP SEMI-CONSTRAINED,UNCEMENTED METAL/POLYER,NON-POROUS,CALCIUM PHOSP
Product CodeMEH
Date Received2020-01-16
Lot Number16LM11733
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No7
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 8

Brand NameSCREW HIP CANC SPHR HEAD 6.5X40MM
Generic NameSCREW, FIXATION, BONE
Product CodeHWC
Date Received2020-01-16
Lot Number14CM21640
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No8
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 9

Brand NameIMPL HIP FEM STEM ECHELON 30X260MM SZ 12
Generic NamePROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS CALCIUM,PHOS
Product CodeMEH
Date Received2020-01-16
Lot Number09DM11378
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No9
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 10

Brand NameIMPL HIP ACET LINER +4 LATERALIZED 36MMX54MM
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL RESURFACING
Product CodeNXT
Date Received2020-01-16
Lot Number17DM01423
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No10
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.

Device Sequence Number: 11

Brand NameIMPL HIP FEM HEAD OXINIUM 12T14 TAPR 4
Generic NamePROSTHESIS HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Product CodeNXT
Date Received2020-01-16
Lot Number17BM01249
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No11
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2020-01-16

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