BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRI TIBIAL BEARING 12X71/75

    MDR report key: 6798740 · Received August 16, 2017

    Report

    Report Number
    0001825034-2017-06354
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 18, 2017
    Report Date
    October 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE IT IS STILL IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    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. MEDICAL PRODUCTS- BMET ARCOM AP PAT W/WIRE 28MM, CATALOG # 11-150825, LOT # 195040; MAXIM POR ANA PRI FML 65 RT, CATALOG # 140052, LOT # 501990; BIOMET ILOK PRI TIB TRAY 75MM, CATALOG # 141214, LOT # 467570; BIOMET FINNED PRI STEM 40MM, CATALOG # 141314, LOT # 437841.

    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 (DHR) 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 A PATIENT UNDERWENT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DAY FOR AN UNKNOWN REASON TO EXCHANGE THE BEARING.

    Description of Event or Problem · 1

    IT IS NOW REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT'S BEARING WAS REVISED DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579750 MAXIM PRI TIBIAL BEARING 12X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 757720

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention