BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI 2 IMPLANT SET

    MDR report key: 5569556 · Received April 12, 2016

    Report

    Report Number
    3004608878-2016-00072
    Event Type
    Injury
    Date Received
    April 12, 2016
    Report Date
    March 28, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER MFR REPORT # 3004608878-2016-00058. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON AUGUST 17, 2016. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: ASSESSMENTS OF PRIOR CUSTOMER COMPLAINTS HAVE IDENTIFIED A NUMBER OF PHYSICAL CONDITIONS OF THE PATIENT WHICH COULD COMPROMISE THE INTEGRITY OF THE IMPLANT. THESE INCLUDE, BUT ARE NOT LIMITED TO: POOR BONE QUALITY WHICH MAY AFFECT THE STABILITY OF THE IMPLANTS; SEVERE TENDON, NEUROLOGICAL, OR VASCULAR DEFICIENCIES WHICH COULD COMPROMISE THE AFFECTED EXTREMITY; ANY CONCOMITANT DISEASE WHICH MAY COMPROMISE THE FUNCTION OF THE IMPLANTS; INFECTIONS; ACUTE OR CHRONIC, LOCAL OR SYSTEMIC: HYPERSENSITIVITY TO THE IMPLANT MATERIAL(S); AND, OBESITY, WHICH PLACES A GREATER WEIGHT LOAD ON THE IMPLANT. ALL SIX CONDITIONS MAY RESULT OR CONTRIBUTE TO PREMATURE FAILURE BY LOOSENING, FRACTURE OR WEAR OF THE IMPLANTS. A SECOND FAILURE MODE IS THAT THE UNIVERSAL2 CARPAL POLYETHYLENE IMPLANT MAY UNDERGO LONG-TERM OXIDATIVE DEGENERATION RESULTING IN DELAMINATION, WHICH APPEARS AS A CRACKED OR BROKEN IMPLANT. THIS CAN RESULT IN PREMATURE FAILURE BY LOOSENING, FRACTURE OR WEAR OF THE IMPLANTS. A THIRD FAILURE MODE, OFTEN OBSERVED IN LONG-TERM ARTHROPLASTY SYSTEMS, IS IMPLANT LOOSENING RESULTING FROM ASEPTIC OSTEOLYSIS. DHR REVIEW: THE PART AND LOT NUMBERS OF THE IMPLANTED UNIVERSAL2 SYSTEM WERE NOT PROVIDED. AS A RESULT, INTEGRA IS UNABLE TO CONDUCT A DEVICE HISTORY RECORD (DHR) REVIEW. COMPLAINTS HISTORY: ELEVEN OTHER CUSTOMER COMPLAINTS ASSOCIATED WITH A FAILED UNIVERSAL2 CARPAL POLYETHYLENE IMPLANT DUE TO DELAMINATION OR OSTEOLYSIS THAT REQUIRED REVISION SURGERY. ONE COMPLAINT FROM A PATIENT WHO COMPLAINED OF POST-OPERATIVE PAIN AND DISCOMFORT, BUT IN WHICH REVISION SURGERY HAD NOT YET BEEN SCHEDULED. CONCLUSION: THIS INVESTIGATION WAS ABLE TO CONFIRM THE NEED FOR A REVISION SURGERY OF AN INTEGRA UNIVERSAL2 TOTAL WRIST SYSTEM. THE CONFIRMATION WAS BASED ENTIRELY ON THE PATIENT¿S MEDICAL CONDITION, AS PROVIDED BY THE COMPLAINANT. ALTHOUGH THE COMPLAINANT SUBMITTED SEVERAL RADIOGRAPHS, ILS (B)(4) IS NOT QUALIFIED TO PROVIDE CLINICAL INTERPRETATION. AS A RESULT, A LIKELY ROOT CAUSE CANNOT BE IDENTIFIED. THE INFORMATION PROVIDED BY THE COMPLAINANT, INCLUDING COPIES OF THE RADIOGRAPHS, WAS FORWARDED TO THE DESIGNER SURGEON FOR THE UNIVERSAL2 TOTAL WRIST SYSTEM AND THE INTEGRA FREEDOM WRIST SYSTEM.

    Description of Event or Problem · 1

    THIS REPORT IS ABOUT A (B)(6) WF WITH HISTORY OF RA. TWA (TOTAL WRIST ARTHROPLASTY) ON DOMINANT WRIST ON (B)(6) 2004. DEVELOPED SWELLING LATE 2014 WITHOUT ANTECEDENT TRAUMA. X-RAY SHOW LYTIC LESION IN RADIUS. NOT MUCH PAIN. MOSTLY SWELLING. LYTIC AREA EXCISED AND MMA PLACED IN VOID. DID WELL FOR A YEAR BUT THEN RETURNED WITH INCREASING PAIN. MORE RE-ABSORPTION AROUND RADIUS AND CEMENTED AREA. CEMENT EXCISED AND BONE GRAFTED. BEING HELD IN CAST NOW FOR TWO MONTHS AWAITING CONSOLIDATION (IF POSSIBLE). SYNOVIAL FLUID WITH A DARK GREEN COLOR. ALL CULTURES AEROBIC, ANAEROBIC, FUNGAL, AFB ARE NEGATIVE. FINAL PATHOLOGIC DIAGNOSIS OF SOFT TISSUE, LEFT WRIST SYNOVIAL EXCISION: FRAGMENTS OF BENIGN SYNOVIAL TISSUE WITH ACTIVE AND CHRONIC INFLAMMATION AND A FOREIGN BODY TYPE GIANT CELL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225789 UNI 2 IMPLANT SET N/A JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other