BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATED RIM LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL

    MDR report key: 5956033 · Received September 16, 2016

    Report

    Report Number
    0001822565-2016-03280
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    October 31, 2014
    Report Date
    December 9, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK120370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2016-03282-1, 0001822565-2016-03282-2).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. PART AND LOT NUMBERS COULD NOT BE PROVIDED, THEREFORE COMPLAINT SEARCH HISTORY AND DEVICE HISTORY REPORTING COULD NOT BE PERFORMED. THE REPORTED DEVICES ARE USED FOR TREATMENT. IT COULD NOT BE CONFIRMED IF THE DEVICE WAS USED IN AN APPROVED AND COMPATIBLE COMBINATION. OPERATIVE NOTES FOR THE INITIAL AND REVISION SURGERY COULD NOT BE OBTAINED. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PAIN CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2016-03282-2).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EXPIRATION DATE - NI. MANUFACTURE DATE - NI. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-03282; 0001822565-2017-08422. CONCOMITANT MEDICAL PRODUCTS: SHELL WITH CLUSTER HOLES CATALOG#: 00875705601 LOT#: NI; FEMORAL HEAD CATALOG#: 00801803602 LOT#: NI; REVISION FEMORAL STEM CATALOG#: 00784301308 LOT#: 62509389; UNKNOWN COCR CABLES WITH TI CRIMP CATALOG#: NI LOT#: NI; UNKNOWN BONE SCREWS CATALOG#: NI LOT#: NI. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE STERILIZATION PROCESS FOR THE DEVICES ARE IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP DUE TO A POST-REVISION SURGERY INFECTION. THE WOUND WAS FOUND TO BE INFECTED, SO THE IMPLANT WAS ONCE AGAIN REMOVED AND AN ANTIBIOTIC SPACER WAS PLACE IN THE PATIENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP DUE TO INFECTION. SHELL, HEAD AND LINER WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608210 ELEVATED RIM LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL HIP PROSTHESIS KWZ ZIMMER, INC. N/A 62720387

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O