BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POLY TIBIAL BUSHING

    MDR report key: 6981882 · Received October 26, 2017

    Report

    Report Number
    0001825034-2017-09677
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    April 25, 2017
    Report Date
    December 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT: OSS AXLE CAT#: 150480, LOT#: 031920; OSS REINFORCED YOKE CAT#: 150493, LOT#: 371430 ; OSS POLY FEMORAL BUSHINGS CAT#: 150477, LOT#: 328870 ; OSS POLY BUMPER LOCK PIN CAT#: 150510, LOT#: 276090 ; OSS TIBIAL POLY BEARING CAT#: 150415, LOT#: 874810 ; 1/8 QUICK REL DRL CAT#: 32-486265, LOT#: 238760; OSS NON-MOD TIBIAL PLATE CAT#: 161042, LOT#: 037590; OSS FEMORAL CAT#: 150357, LOT#: 974400; SERIES A PAT STD 34 3 PEG CAT#: 184766, LOT#: 914970; INTRAMEDULLARY PLUG XL CAT#: 130615, LOT#: 538740; OSS CEMENTED IM STEM CAT#: 150370, LOT#: 722420; OSS TIBIAL BLK AUG CAT#: 150427, LOT#: 376230 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09676, 0001825034 - 2017 - 09677, 0001825034 - 2017 - 09678, 0001825034 - 2017 - 09679, 0001825034 - 2017 - 09680, 0001825034 - 2017 - 09681. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BEARING REVISION FIVE MONTHS AFTER INITIAL LEFT KNEE ARTHROPLASTY DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BEARIG REVISION FIVE MONTHS AFTER INITIAL LEFT KNEE ARTHROPLASTY DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759393 OSS POLY TIBIAL BUSHING PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 554470

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R