PIP UNK XXX-PIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-01-06 for PIP UNK XXX-PIP manufactured by Ascension Orthopedics.

Event Text Entries

[15263553] This is the fourth report of four concerning the same patient. This report concerns the right hand middle finger - distal pyrocarbon pip implant. It was reported "during my investigation online, i found that your implants may cause synovitis. I experienced this in my right wrist. Therefore, i contacted the doctor who did this surgery and found out these were also ascension. I had the two implants put in pointing and middle finger in the later part of 2009. I began having some problems and went back to the doctor. He said i needed a tenosynovectomy. This was done immediately. He repaired 5 tendons that were to the point of rupture. I still have numbness in the right side on my hand and continuing soreness in my wrist. These implants are still functioning okay but i'm concerned now about the potential for more tendon problems. I would like to know what research has shown on this and long tern effects. Additional information was received on (b)(4) 2013. It was reported the implant was 'pyrocarbon pip. Additional information was requested by integra, no other information was provided. This is the same patient previously referenced in mfg report numbers 1651501-2013-00036 and 1651501-2013-00037.
Patient Sequence No: 1, Text Type: D, B5


[15541102] The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1651501-2013-00049
MDR Report Key3565394
Report Source04
Date Received2014-01-06
Date of Report2013-12-13
Date Mfgr Received2013-12-13
Date Added to Maude2014-01-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCAREN FINKELSTEIN
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePIP UNK
Generic NamePIP
Product CodeNEG
Date Received2014-01-06
Catalog NumberXXX-PIP
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer AddressAUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-01-06

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