BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPAEDIC SALVAGE SYSTEM- OSS 2MM SPIKED WASHER BOLT

    MDR report key: 6675823 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04408
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 17, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK141331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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)(4). MEDICAL PRODUCTS- OSS 0 MM SPIKED WASHER BOLT CATALOG #: 151825 LOT #: 643320, OSS 9 CM OSSEOTI PROX TIB SLV CATALOG #: 151819 LOT #: 677310, OSS SPIKED WASHER CATALOG #: 151824 LOT #: 866750. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE REPORTED FOR THIS EVENT. 0001825034-2017-04407.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING. IT WAS SEEN ON X-RAY, THAT TWO OF THE BOLTS BACKED OUT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453437 BIOMET ORTHOPAEDIC SALVAGE SYSTEM- OSS 2MM SPIKED WASHER BOLT PROTHESIS, HIP JDI BIOMET ORTHOPEDICS 643330

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R