BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI FEMORAL MD

    MDR report key: 8751943 · Received July 2, 2019

    Report

    Report Number
    3002806535-2019-00560
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    June 28, 2019
    Report Date
    January 31, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388073
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE VISUAL INVESTIGATION CONFIRMED THE REPORTED EVENT. THE CEMENT MANTLE WAS FOUND TO BE UNEVEN BUT WELL ATTACHED TO THE TIBIAL AND FEMORAL COMPONENTS, COVERING MOST OF THE NON - ARTICULATING SURFACE AND SLIGHTLY OVERHANGING FROM THE CEMENT POCKET. THERE IS LITTLE EVIDENCE OF BONE INTEGRATION ON TIBIAL TRAY AND THE FEMORAL COMPONENT. THERE ARE LIGHT SCRATCHES ON THE ARTICULATING SURFACE OF THE FEMORAL COMPONENT. DEEP SCRATCHES ARE VISIBLE ON THE ARTICULATING SURFACES OF THE TIBIAL TRAY, THE SURFACE DAMAGE COULD HAVE APPEARED DURING IMPLANT REMOVAL. CONSIDERING THAT THE IMPLANT WAS IN USE FOR OVER 12 YEARS THE POLYETHYLENE BEARING IS IN OVERALL GOOD CONDITION. SOME PITTING AND LIGHT STARCHES ARE OBSERVED ON THE BEARING SURFACE, THIS INDICATES THAT THERE MIGHT HAVE BEEN SOME THIRD BODIES PRESENT IN THE JOINT SPACE, HOWEVER THIS CANNOT BE CONFIRMED WITHOUT RADIOGRAPHIC IMAGES. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED IN THE COMPLAINT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS SCHEDULED TO BE REVISED DUE PAIN AND KNEE LOCKING UP.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, REVISION SURGERY PERFORMED DUE PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXFORD UNI TIB TRAY44X28 LLRM ITEM #: 154610 LOT #: 1157476, MEDICAL PRODUCT: OXFORD UNI TIB BRG MED SZ6. ITEM #: 154629. LOT #: 1183029, ASSOCIATED PRODUCT: COBALT-G HV BONE CEMENT 40GM B. ITEM #: 402433. LOT #: 974350. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00562, 3002806535-2019-00563. 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 A PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS SCHEDULED TO BE REVISED DUE TO HER KNEE LOCKING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545781 OXFORD UNI FEMORAL MD KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 1230424 05019279388073

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10