BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPAL POLY MEDIUM- STD.

    MDR report key: 5085352 · Received September 17, 2015

    Report

    Report Number
    3004608878-2015-00247
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    March 11, 2015
    Report Date
    August 24, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSLATION OF THE DOCUMENT (IN (B)(4) LANGUAGE) WAS RECEIVED IN (B)(6) 2015 : COMMENTS FROM THE HOSPITAL : "ENCLOSED YOU WILL FIND THE IMPLANT CARD OF A PATIENT IN OUR TREATMENT. THIS PATIENT HAD PREVIOUSLY RECEIVED IMPLANTS IN THE REGION OF THE LEFT WRIST. CURRENTLY CONTACT DERMATITIS IS SUSPECTED, AND IN ORDER TO RULE OUT THAT THIS IS CAUSED BY A REACTION TO THE IMPLANT WE WOULD KINDLY ASK YOU TO PROVIDE US SAMPLE MATERIAL OF THE IMPLANT USED. IT IS PLANNED TO CARRY OUT PERCUTANEOUS TESTING WITH THESE MATERIALS. IN THIS TEST THE MATERIAL IS STUCK ONTO THE BACK TO DEMONSTRATE ANY ALLERGIC REACTION. ALLERGIC REACTIONS TO IMPLANT MATERIALS ARE EXTREMELY RARE, THE TESTING WILL ALSO BE CARRIED OUT ON THE REQUEST OF THE TREATING ORTHOPAEDIC SURGEON. DUE TO THE PRESENTATION A CONTACT ALLERGY TO IMPLANT MATERIALS IS CURRENTLY NOT ASSUMED, BUT A CONTACT ALLERGY OUGHT TO BE RULED OUT. THE TEST MATERIALS SHOULD NOT BE RAW MATERIALS, BUT, FOR EXAMPLE, FULLY HARDENED MATERIAL, JUST AS HAS BEEN USED." THERE ARE 3 SUBMISSIONS ASSOCIATED WITH THIS EVENT. MFG REPORT NUMBERS - 3004608878-2015-00246, 3004608878-2015-00247, 3004608878-2015-00248 INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2015. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. REVIEW OF DEVICE HISTORY RECORDS DETERMINED THAT THERE IS NO EVIDENCE OF ANY MATERIAL DEFECTS OR VARIANCES ASSOCIATED WITH CARPAL POLYETHYLENE IMPLANT LOT # FX0104. SEVENTY (70) OF THE CARPAL POLYETHYLENE IMPLANTS FROM LOT # FX0104 WERE SENT TO INTEGRA (B)(4) FOR PACKAGING AND GAMMA STERILIZATION AND WERE RETURNED TO INTEGRA (B)(4), INSPECTED AND RELEASED INTO INVENTORY ON FEBRUARY 20, 2013. THERE WERE NO NON-CONFORMANCES OR VARIANCES ASSOCIATED WITH THE PACKAGING AND STERILIZATION. A QUERY OF THE ELECTRONIC COMPLAINT SYSTEM DID NOT IDENTIFY OTHER CUSTOMER COMPLAINTS ASSOCIATED WITH A REPORTED ALLERGIC REACTION. BASED ON THE LIMITED AMOUNT OF INFORMATION PROVIDED IN THE COMPLAINT, INTEGRA IS UNABLE TO CONFIRM THAT THE PATIENT SUFFERED AN ALLERGIC REACTION DUE TO DIRECT CONTACT WITH THE COMPONENTS THAT MAKE UP THE UNIVERSAL2 TOTAL WRIST SYSTEM. AT THE REQUEST OF (B)(6), INTEGRA SENT THE FOLLOWING PARTS TO (B)(4) FOR PERCUTANEOUS TESTING: ¿ UNIVERSAL2 MEDIUM STANDARD CARPAL POLY, P/N 26-2300, LOT # 11052-30-11065; ¿ UNIVERSAL2 MEDIUM CARPAL PLATE, P/N 261301, LOT # 10703S-13-11081; ¿ UNIVERSAL2 MEDIUM, LEFT, RADIAL, P/N 263300LF, LOT # 10045-33L-10570. THIS INVESTIGATION REPORT WILL BE REVISED ONCE (B)(6) HAS COMPLETED THE PERCUTANEOUS TESTING AND HAS ISSUED THE RESULTS. CONCLUSION: BASED ON THE LIMITED AMOUNT OF INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. THIS INVESTIGATION REPORT WILL BE REVISED ONCE (B)(6) HAS COMPLETED THE PERCUTANEOUS TESTING AND HAS ISSUED THE RESULTS.

    Description of Event or Problem · 1

    THIS EVENT IS ASSOCIATED WITH 3 DEVICES FROM A DEVICE SYSTEM. THIS REPORT IS FOR DEVICE 2 OF 3. IT WAS REPORTED THE PATIENT HAD A POSSIBLE ALLERGIC REACTION. THE PATIENT HAD 3 IMPLANTS FROM A WRIST IMPLANTATION DEVICE SYSTEM, IMPLANTED ON (B)(6) 2009. A REVISION SURGERY TOOK PLACE ON (B)(6) 2015. THIS DEVICE WAS IMPLANTED TO REPLACE A REMOVED DEVICE. REGARDING THE REMOVED DEVICE, THE DEVICE ((B)(4) / LOT 11052-30-11065) WAS REMOVED DURING REVISION SURGERY : NOT IMPLANTED WHEN ALLERGIC REACTION (OCCURRED). IT WAS LATER REPORTED, "THIS (THE REMOVED) DEVICE WAS REMOVED DUE TO NORMAL WEAR OF THE DEVICE. THE PATIENT WAS FINE. DUE TO THE SURGERY, THE PATIENT HAS AN INFLAMMATORY REACTION. THE SURGEON JUST WANTS TO BE SURE THIS INFLAMMATORY REACTION IS NOT DUE TO ALLERGIC REACTION. THIS IS WHY HE REQUESTED SAMPLES FOR ALLERGIC TEST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615209 CARPAL POLY MEDIUM- STD. UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA FX0104

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other