BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 4 PMA

    MDR report key: 7116388 · Received December 14, 2017

    Report

    Report Number
    3002806535-2017-01198
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    March 14, 2017
    Report Date
    March 12, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE MEDICAL RECORDS PROVIDED BY THE PATIENT REPORT THAT THE PATIENT ¿WAS STRETCHING AND PULLED ON HER DOG WITH HER LEGS EXTENDED¿ WHEN THE BEARING DISLOCATED. THE SURGEON ALSO INDICATED THAT THE PATIENT DEVELOPED SIGNIFICANT OSTEOARTHRITIS IN HER PATELLA AND LATERAL COMPARTMENT, THEREFORE HE RECOMMENDED CONVERSION TO A TOTAL KNEE ARTHROPLASTY. BASED ON THE AVAILABLE EVIDENCE, PATIENT TRAUMA AS WELL AS OSTEOARTHRITIS PROGRESSION WERE THE MOST LIKELY CAUSE OF THE REPORTED BEARING DISLOCATION. 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). THIS EVENT HAS BEEN PREVIOUSLY REPORTED UNDER REFERENCE NUMBERS: 0001822565-2017-07791 AND 0001822565-2017-07792. (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF TWIN-PEG CMNTD FEM SM PMA, ITEM NO: 161468, LOT NO: 3011965, OXFORD PKS COCR SIZE A RM STD, ITEM NO: 154719, LOT NO: 2991832. 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 WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED DUE TO BEARING DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898527 OXF ANAT BRG RT SM SIZE 4 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2932812

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R