MAUDE MDR 5138146

MDR report key
5138146
Report number
0001825034-2015-04171
Event key
0
Event type
3
Date of event
2015-09-08
Date received
2015-10-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. MEGAN HAAS
Address
56 E. BELL DRIVE WARSAW IN 46582 US
Phone
574-574-5743
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1G7 NEUTRAL E1 LINER 32MM FPROSTHESIS, HIPBIOMET ORTHOPEDICSLKDN/A0100008503471472R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-0801. R

Event Narratives#

N

Patient 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DATE OF BIRTH - 1946, EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ? UNKNOWN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ?MATERIAL SENSITIVITY REACTIONS.? NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04169 / 04171 & 04235).

D

Patient 1

IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2015 TO BE TREATED WITH MEDICATION DUE TO AN INFECTION WITH MODERATE TRACES OF STAPH. AUREUS. NO REVISION HAS YET BEEN REPORTED.

N

Patient 1

THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT AND RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

N

Patient 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REMAINS IMPLANTED.

N

Patient 1

UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.