BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 16MM TIBIAL BEARING

    MDR report key: 6549730 · Received May 5, 2017

    Report

    Report Number
    0001825034-2017-03134
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    May 18, 2015
    Report Date
    October 31, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: 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-K 67 MM MODULAR POROUS COATED W/PLUG TIBIAL BASE, ITEM #: CP102513, LOT #: 684410. 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:0001825034-2017-03140, 0001825034-2017-03127, 0001825034-2017-03129, 0001825034-2017-03130, 0001825034-2017-03131, 0001825034-2017-03132, 0001825034-2017-03133, 0001825034-2017-03135, 0001825034-2017-03136, 0001825034-2017-03138, AND 0001825034-2017-03139.

    Additional Manufacturer Narrative · 1

    UPON RECEIVING ADDITIONAL INFORMATION ON THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS ONLY THE PATIENT'S YOKE WAS REPLACED DUE TO A FRACTURE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329356 OSS 16MM TIBIAL BEARING PROTHESIS, HIP JDI BIOMET ORTHOPEDICS 485450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R