BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TM YOKE

    MDR report key: 6549737 · Received May 5, 2017

    Report

    Report Number
    0001825034-2017-03140
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    May 18, 2015
    Report Date
    June 25, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 PRODUCTS - OSS POROUS COATED IM STEM W/SCREW - 11.5 MM X 90 MM, ITEM #: 150382, LOT #: 339930; OSS SEGMENTAL FEMORAL - LEFT 7 CM, ITEM #: 150355, LOT #: 190480; OSS POROUS COATED BOWED IM STEM W/SCREW, ITEM #: 150402, LOT #: 249770; OSS-K DIAPHYSEAL SEGMENT 4CM W/SCREWS, ITEM #: CP111275, LOT #: 011040; OSS POROUS COATED BOWED IM STEM W/SCREW, ITEM #: 150403, LOT #: 614490; OSS 16MM TIBIAL BEARING, ITEM #: 150412, LOT #: 485450; OSS FEMORAL BUSHINGS, ITEM #: 150477, LOT #: 381710; OSS TIBIAL BUSHING, ITEM #: 150476, LOT #: 337250; OSS AXLE, ITEM #: 150480, LOT #: 193670; OSS LOCKING PIN, ITEM #: 150478, LOT #: 823670; OSS TM YOKE, ITEM #: 150493, LOT #: 190730. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CURRENT LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-03127, 0001825034-2017-03129, 0001825034-2017-03130, 0001825034-2017-03131, 0001825034-2017-03132, 0001825034-2017-03133, 0001825034-2017-03134, 0001825034-2017-03135, 0001825034-2017-03136, 0001825034-2017-03138, AND 0001825034-2017-03139.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE YOKE FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329455 OSS TM YOKE PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 190730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R