BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 16681653 · Received April 5, 2023

    Report

    Report Number
    3002806535-2023-00098
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    November 8, 2022
    Report Date
    May 4, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438242
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UNKNOWN OXFORD BEARING; ITEM#UNKNOWN; LOT#UNKNOWN. UNKNOWN OXFORD TIBIAL; ITEM#UNKNOWN; LOT#UNKNOWN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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 - 00099 3002806535 - 2023 - 00100. OTHER TEXT : PART AND LOT NUMBER UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: OXF ANAT BRG LT MD SIZE 3 PMA; ITEM#159547; LOT#2965903. OXF UNI TIB TRAY SZ C LM PMA; ITEM#154722; LOT#754150. PALACOS R 1X40 SINGLE; ITEM#00-1112-140-01; LOT#76384339. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF OP RECORD STATED THAT PATIENT PRESENTED WITH SEVERE PAIN FOR ONE WEEK AND THAT THE PREOP DIAGNOSIS IDENTIFIED A FAILED ORTHOPEDIC LEFT PARTIAL KNEE IMPLANT THAT REQUIRED REPLACEMENT. SUPPORTING X-RAY SHOWED A FRACTURE OF THE FEMORAL COMPONENT AND POLYETHYLENE COMPONENT WAS WORN AND FRACTURED WHICH CONTRADICTED X-RAY FINDINGS. FEMORAL COMPONENT REMOVED WITH MINIMAL BONE LOSS, NOTED CAVITARY DEFECT FROM POLY WEAR TO THE MEDIAL CONDYLE, DISEASED NECROTIC OR FIBROTIC TISSUE REMOVED WITH RADICAL SYNOVECTOMY TO WHOLE KNEE. PREVIOUS INCISION UTILIZED WITH SIGNIFICANT SCAR TISSUE AND METALLOSIS ENCOUNTERED. TIBIA COMPONENT EXCISED AND NOTED SOME CAVITARY DEFECT FROM POLY WEAR. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION AND FULL RANGE OF MOVEMENT & STABILITY WAS EXPERIENCED THROUGHOUT. POST OP X-RAY CONFIRMED THAT TKA WAS SATISFACTORY, LONG STEM TIBIAL COMPONENT IS NOTED. SUBCUTANEOUS EMPHYSEMA WAS PRESENT HOWEVER, THIS WAS DEEMED TO BE NORMAL IMMEDIATELY POST OP. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN IMPLANT FRACTURE, APPROXIMATELY 9 YEARS POST IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED INITIAL LEFT UNICOMPARTMENTAL ARTHROPLASTY. SUBSEQUENTLY REVISED DUE TO SEVERE PAIN FOR ONE WEEK AND FRACTURED IMPLANT. DURING THE REVISION NOTED POLY FRACTURE AND WEAR, SCAR TISSUE, BONE DEFECT FROM POLY WEAR, TISSUE DAMAGE, AND METALLOSIS. ALL COMPONENTS WERE EXCHANGED, AND PATELLA IMPLANTED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008284 OXF TWIN-PEG CMNTD FEM MD PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 505080 05019279438242

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H