BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SEGMENTAL FEMORAL

    MDR report key: 6997610 · Received November 2, 2017

    Report

    Report Number
    0001825034-2017-09892
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    July 29, 2015
    Report Date
    February 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MEDICAL DEVICE: OSS POLY BUMPER LOCK PIN CAT#: 150510, LOT#: 787510. OSS REINFORCED YOKE CAT#: 150493, LOT#: 546030. OSS REINFORCED FEMORAL BUSHINGS CAT#: 161034, LOT#: 252670. OSS REINFORCED AXLE CAT#: 161035, LOT#: 239890. OSS POLY TIBIAL BUSHING CAT#: 150476, LOT#: 963640. COMPRESS TAPER ADAPTER CAT#: 178711, LOT#: 250760 . OSS TIBIAL POLY BEARING CAT#: 150411, LOT#: 061070. OSS DIAPHYSEAL SEGMENTAL CAT#: 150468, LOT#: 410890. 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 - 09892, 0001825034 - 2017 - 09896, 0001825034 - 2017 - 09898, 0001825034 - 2017 - 09899, 0001825034 - 2017 - 09900, 0001825034 - 2017 - 09901, 0001825034 - 2017 - 09902, 0001825034 - 2017 - 09903, 0001825034 - 2017 - 09904.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09896-1, 0001825034 - 2017 - 09898-1, 0001825034 - 2017 - 09899-1, 0001825034 - 2017 - 09900-1, 0001825034 - 2017 - 09901-1, 0001825034 - 2017 - 09902-1, 0001825034 - 2017 - 09903-1, 0001825034 - 2017 - 09904-1. 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. 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 THAT THE PATIENT WAS REVISED SEVEN MONTHS FOLLOWING THE TOTAL KNEE ARTHROPLASTY DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777362 OSS SEGMENTAL FEMORAL PROSTHESIS, HIP KRO ZIMMER BIOMET, INC. N/A 059050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10