BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ B LM PMA

    MDR report key: 7037233 · Received November 16, 2017

    Report

    Report Number
    3002806535-2017-01002
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    September 27, 2017
    Report Date
    May 14, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS WERE RETURNED TO BIOMET ORTHOPEDICS LLC FOR EVALUATION AND INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCTS NOTED FOREIGN MATERIAL CONSISTENT WITH BONE CEMENT ON THE CEMENTING SIDE OF THE METAL COMPONENTS. ALSO NOTED NICKS AND DINGS ON THE POLISHED SIDE OF THE TIBIAL COMPONENT AND SCRATCHES ON THE ARTICULAR SURFACE. NO OTHER DAMAGE WAS FOUND ON THE RETURNED PRODUCTS. REVIEW OF DHR IDENTIFIED NO DEVIATIONS/ ANOMALIES REVIEW OF THE PROVIDED INFORMATION INDICATES THAT THE PATIENT HAD ARTHRITIS THAT HAD PROGRESSED TO THE LATERAL COMPARTMENT WHICH LEADS TO SUBSIDENCE OF THE IMPLANTS. THE COMPLAINT REPORT IS NON-VERIFIABLE AS DISEASE PROGRESSION COULD NOT BE CONFIRMED WITH THE PROVIDED IMPLANTS. THE ROOT CAUSE OF THE REVISION IS ATTRIBUTED TO THE PATIENT'S DISEASE PROGRESSION. THE TIBIAL COMPONENT WAS LIKELY CONFORMING WHEN THEY WERE RELEASED FROM ZIMMER BIOMET CONTROL AFTER REVIEW OF THE DEVICE HISTORY RECORDS MANUFACTURING INSPECTION REPORTS. A REVIEW OF THE COMPLAINTS DATA BASE FOR THE PAST 3 YEARS HAS FOUND NO SIMILAR REPORTED EVENTS FOR SUBSIDENCE WITH DISEASE PROGRESSION WITH THIS ITEM. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED, AND SUBSEQUENTLY A SUPPLEMENTAL REPORT WILL BE PROVIDED WHERE DEEMED REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 159550, OXF ANAT BRG LT MD SIZE 6 PMA, LOT 148940, 161469, OXF TWIN-PEG CMNTD FEM MD PMA, LOT 804020. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A BILATERAL KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON THE LEFT KNEE DUE TO TIBIAL COMPONENT SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818732 OXF UNI TIB TRAY SZ B LM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 299710

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R