BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE

    MDR report key: 6731176 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-05047
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    May 25, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE 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

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS TIB POLY BEARING CATALOG #: 150415 LOT #: 185130; OSS AXLE CATALOG #: 150480 LOT #: 110030 ; OSS POLY LOCK PIN CATALOG #: 150478 LOT #: 554480; OSS CEMENTED IM STEM 11X225 CATALOG #: 150373 LOT #: 122650; OSS NON-MOD TIB PLATE LONG 63 CATALOG #: 150419 LOT #: 832880; OSS TIB BLK AUG 10X63/67 UNIV CATALOG #: 150426 LOT #: 372960; OSS TIB BLK AUG 10X63/67 UNIV CATALOG #: 150426 LOT#: 015010; OSS 7CM SEGMENTAL FEMORAL RT CATALOG#: 150354 LOT #: 171260; OSS 4CM DIAPHYSEAL SEGMENT CATALOG #: 150482 LOT #: 727410; OSS POLY FEMORAL BUSHINGS 2PK CATALOG #: 150477 LOT #: 167940; OSS POLY TIBIAL BUSHING CATALOG #: 150476 LOT #: 678220. 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: 0001825034-2017-02304, 0001825034-2017-05047, 0001825034-2017-06492, 0001825034-2017-06493.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02304, 05047. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. COMPLAINT HISTORY WAS UNABLE TO BE PERFORMED, AS THE PART NUMBER AND LOT NUMBER ARE UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    A PATIENT WHO UNDERWENT A KNEE ARTHROPLASTY HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASONS. A REQUEST WAS MADE FOR A CUSTOM EXTENDED YOKE WITH TIBIAL BEARING FOR ORTHOPAEDIC SALVAGE SYSTEM. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511429 ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 220770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN OSS TIBIAL BEARING, CAT#: NI, LOT#: NI