BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT SM SIZE 7 PMA

    MDR report key: 16270863 · Received January 31, 2023

    Report

    Report Number
    3002806535-2023-00033
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 11, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785902
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF UNI TIB TRAY SZ B LM PMA ITEM# 154720 LOT# 960970. OXF TWIN-PEG CMNTD FEM SM PMA ITEM# 161468 LOT# 591120. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2023-00025. 3002806535-2023-00034.

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. SIGNIFICANT FINDINGS INCLUDE APPARENT FEMORAL IMPLANT LOOSENING AND BEARING DISLOCATION WITH TIBIOFEMORAL SUBLUXATION AS NOTED. IMPLANT SIZE APPEARS APPROPRIATE AND THERE IS NO RADIOGRAPHIC EVIDENCE OF TRAUMA OR INJURY. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, B4, B5, D6, G3, G6, H1, H2, H10 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT KNEE DUE TO ASEPTIC LOOSENING AND DISLOCATION OF MOBILE BEARING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991202 OXF ANAT BRG LT SM SIZE 7 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 299900 05019279785902

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention| H SEE H10 NARRATIVE