BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPAL POLY, SMALL- STD.

    MDR report key: 6082856 · Received November 7, 2016

    Report

    Report Number
    3004608878-2016-00299
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 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

    SUMMARY OF ADDITIONAL INFO RECEIVED 14NOV2016: THE METAL IMPLANTS WERE DESTROYED IN THE PROCESS OF TAKING THEM OUT AND WERE UNSALVAGEABLE. POSTOPERATIVE PROTOCOL WAS FOLLOWED. THIS PARTICULAR SURGEON HAS PERFORMED SEVERAL TOTAL WRIST ARTHROPLASTIES. NO UNUSUAL EVENTS/TRAUMA WERE REPORTED POST OP. THERE WERE NO COMPLICATIONS DURING THE INITIAL IMPLANTATION. THE DOCTOR BELIEVES THAT THE PATIENT HAD A REACTION TO POLYWEAR. CURRENT PATIENT STATUS IS UNKNOWN. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 7DEC2016. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: REVIEW OF DEVICE HISTORY RECORDS DETERMINED THAT THE CARPAL POLYETHYLENE IMPLANT (P/N 26-2200, LOT # FX0036), CONSISTING OF A QUANTITY OF 182 PIECES, WAS MANUFACTURED BY AN EXTERNAL SUPPLIER AND RECEIVED AT ILS (B)(4) ON JUNE 10, 2010, INSPECTED AND RELEASED INTO INVENTORY ON JUNE 22, 2010. THERE WERE NO MATERIAL NON-CONFORMANCES OR VARIANCES ASSOCIATED WITH THE INSPECTIONS OF LOT # FX0036. A QUERY WAS PERFORMED TO IDENTIFY OTHER CUSTOMER COMPLAINTS ASSOCIATED WITH A FAILED UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM THAT WOULD REQUIRE REVISION SURGERY. THE QUERY WAS LIMITED JUST TO COMPLAINTS IN WHICH THERE WAS A FAILED CARPAL POLYETHYLENE IMPLANT DUE TO DELAMINATION OR OSTEOLYSIS. THE QUERY RETURNED TWELVE OTHER CUSTOMER COMPLAINTS ASSOCIATED WITH A FAILED UNIVERSAL2 CARPAL POLYETHYLENE IMPLANT DUE TO DELAMINATION OR OSTEOLYSIS THAT REQUIRED REVISION SURGERY. THE QUERY ALSO FOUND ONE COMPLAINT FROM A PATIENT WHO COMPLAINED OF POST-OPERATIVE PAIN AND DISCOMFORT, BUT IN WHICH REVISION SURGERY HAD NOT YET BEEN SCHEDULED. A TREND ANALYSIS COMPLAINT RATE WAS PERFORMED BY DETERMINING THE NUMBER OF REPORTED NON-CONFORMANCES FOR THE UNIVERSAL2 TOTAL WRIST SYSTEM CARPAL POLYETHYLENE IMPLANTS. (B)(4). CONCLUSION: BASED ON THE FINDINGS OF THIS INVESTIGATION THE LIKELY ROOT CAUSE FOR THIS CUSTOMER COMPLAINT WAS DUE TO PARTICLE-INDUCED OSTEOLYSIS AROUND THE IMPLANT, WHICH LEAD TO ASEPTIC LOOSENING. THE APPEARANCE OF THE EXPLANTED DEVICE IS CONSISTENT WITH WEAR PATTERNS RESULTING FROM MECHANICAL LOSS OVER TIME, RESULTING IN FURTHER BREAKDOWN OF THE IMPLANTS, ESPECIALLY THE CARPAL POLYETHYLENE IMPLANT. THE CAUSES OF PARTICLE ACCUMULATION VARY FROM IMPLANT INTERFACE WEAR, MICROMOTION OCCURRING IN RESPONSE TO CORROSION OR FROM THE BONE SCREWS MOVING/RUBBING WITHIN THE BARRELS OF THE CARPAL IMPLANT, OXIDATIVE REACTIONS AND MINOR PATHOGEN CONTAMINATIONS. WITH THE EXCEPTION OF MINOR PATHOGEN CONTAMINANTS, ALL OF THESE CONDITIONS ARE KNOWN FAILURE MODES FOR THE UNIVERSAL2 SYSTEM. BASED ON THE LIMITED AMOUNT OF INFORMATION THAT WAS PROVIDED BY THE COMPLAINANT AND WITHOUT REVIEWING THE MOST RECENT RADIOGRAPHS OR THE EXPLANTED CARPAL PLATE, BONE SCREWS AND RADIAL IMPLANT, IT ISN¿T POSSIBLE TO DETERMINE WHICH FAILURE MODE(S) WOULD HAVE BEEN THE MOST PROMINENT FOR PARTICLE ACCUMULATION. THE PROBABLE ROOT CAUSE IS DUE TO IMPLANT INTERFACE WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS REMOVED DUE TO POSTOPERATIVE COMPLICATIONS. "PATIENT HAD PAINFUL HARDWARE AFTER A UNIVERSAL TOTAL WRIST. THE SURGEON THINKS THE PATIENT WAS HAVING PAIN CAUSED BY POLY DEBRIS. THE POLY HAD SOME WEAR ON THE EDGES. ALL IMPLANTS WERE REMOVED. BOTH THE CARPAL AND RADIAL IMPLANTS REQUIRED BURRING TO REMOVE FROM THE PATIENT. NO IMPLANTS WERE USED IN THE REVISION." IT WAS REPORTED THE DEVICE WAS IN CONTACT WITH THE PATIENT; PATIENT INJURY IS UNKNOWN. REVISION/MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO SURGERY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734506 CARPAL POLY, SMALL- STD. JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA FX0036

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention