BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PH3 CEMENTLESS FEM SZ S

    MDR report key: 6461626 · Received April 5, 2017

    Report

    Report Number
    3002806535-2017-00192
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    February 23, 2017
    Report Date
    October 5, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS¿ OXFORD ANATOMICAL BEARING CATALOG 159568, LOT 3113113; OXFORD TIBIAL TRAY CATALOG 166573, LOT 3226041. (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P010014. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 3002806535-2017-00193 AND 3002806535-2017-00194.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. ANALYSIS OF THE RETRIEVED IMPLANTS AND RADIOGRAPHS DID NOT SHOW ANY OBVIOUS SOURCE OF MATERIAL LOSS THAT MAY HAVE CONTRIBUTED TO THE REPORTED METALLOSIS. A SCRATCH RUNNING DOWN THE LATERAL SIDE OF THE FEMORAL COMPONENT MAY INDICATE SOME INTERACTION WITH THE RAIL OF THE TIBIAL TRAY, HOWEVER, THERE IS NO CORRESPONDING MARKING ON THE TIBIAL TRAY WITH THIS DAMAGE. REVIEW OF AP RADIOGRAPH SHOWS THE FEMORAL COMPONENT TO BE POSITIONED CENTRALLY WITHIN THE JOINT SPACE AND CLEAR OF THE TIBIAL RAIL. THERE IS SOME EVIDENCE TO INDICATE FEMORAL LOOSENING, THE RADIOLUCENT REGION ON THE LATERAL RADIOGRAPH SURROUNDING THE FEMORAL PEG MAY INDICATE PEG MOVEMENT AND THE SMALL AMOUNT OF ANTERIOR BURNISHING MAY ALSO INDICATE MICRO-MOTIONS AS A RESULT OF LOOSENING ACTING UPON THIS REGION OF THE IMPLANT. HOWEVER THE MAJORITY OF THE COATING APPEARS TO BE INTACT AND UNDAMAGED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED AS THE EVENT WAS NOT CONFIRMED. 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 UNDERWENT A REVISION OF A RIGHT PARTIAL KNEE PROSTHESIS APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO METALLOSIS OF THE KNEE JOINT, WEAR, AND POSSIBLE ABRASION OF THE FEMORAL COATING. THE PATIENT WAS CONVERTED TO A TOTAL KNEE PROSTHESIS. 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
    243403 OXFORD PH3 CEMENTLESS FEM SZ S PROSTHESIS, KNEE JWH BIOMET UK LTD. 3244323

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R NARRATIVE