BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TWIN-PEG FEMORAL MD

    MDR report key: 18674291 · Received February 9, 2024

    Report

    Report Number
    3002806535-2024-00046
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279132478
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: OXF UNI TIB TRAY SZ D LM; ITEM# 154724; LOT# 3945434. OXF ANAT BRG LT MD SIZE 3 PMA; ITEM# 159547; LOT# 3923497. PALACOS CEMENT; ITEM# 66017747; LOT# 86574616. G2 - FOREIGN: GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE RETURNED DEVICE WAS REVIEWED WITH VISUAL EXAMINATION AND OPTICAL MICROSCOPY USING A KEYENCE DIGITAL MICROSCOPE. POSSIBLE CRACK INITIATION SITES AND BEACH MARKS ARTEFACTS WERE IDENTIFIED SUGGESTING THAT THE DEVICE FRACTURED DUE TO FATIGUE. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. 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 THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW OF THE INITIAL OP NOTES IDENTIFIED THE FOLLOWING POINTS: EXTENSIVE DEFECT IN THE MEDIAL FEMORAL CONDYLE NOTED. CLEAR SIGNS OF CHONDROLYSIS WITH EXPOSED CANCELLOUS BONE PARTS AND PRONOUNCED EFFUSION AND SYNOVITIS. OSTEOPHYTES REMOVED. PARTIAL MEDIAL COMPONENTS CEMENTED INTO PLACE. PARTIAL LOAD 20KG ON FOREARM CRUTCHES FOR 2-4 WEEKS (DUE TO THE SOFT SITUATION ON THE MEDIAL FEMORAL CONDYLE). THE REVIEW OF THE REVISION OP NOTES IDENTIFIED THE FOLLOWING POINTS: PATIENT FIRST PRESENTED WITH MICRO INSTABILITY SHOWN BY RADIOGRAPHY, PATIENT HAS NEVER BEEN SYMPTOM FREE (STATED AS PERSISTENT PAIN IN THE PER). PATIENT PRESENTED THREE DAYS PRIOR IN EMERGENCY DEPARTMENT WHERE X-RAY SHOWED A FRACTURED FEMORAL COMPONENT, PATIENT DENIED FALL OR TRAUMA. ASPIRATION PERFORMED WHICH WAS NEGATIVE FOR SIGNS OF INFECTION. PREOP ROM 50-20-0 (DIMINISHED). CHRONIC SYNOVITIS NOTED. THE BROKEN POSTERIOR PART OF THE FEMORAL COMPONENT IS REMOVED WITHOUT ANY PROBLEMS. THE VENTRAL PART IS FIRMLY ANCHORED IN THE FEMORAL CONDYLE WITH THE TWO PEGS. ALL INITIAL IMPLANTS AND CEMENT REMOVED. NEXGEN TKA COMPONENTS PLACED (NO PATELLAR IMPLANT). ON THE MEDIAL SIDE, THERE IS A BONE DEFECT OF APPROX. 8MM; THEREFORE, THE DECISION WAS MADE TO IMPLANT A WEDGE. TKA IMPLANTS CEMENTED IN PLACE WITHOUT COMPLICATION. X-RAY CONFIRMS CORRECT POSITION WITHOUT FRACTURE. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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 A PATIENT HAD AN INITIAL LEFT MEDIAL UNICONDYLAR KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED PERSISTENT PAIN AND FIRST PRESENTED WITH MICROINSTABILITY WITHIN THE JOINT. NEARLY 7 YEARS POSTOP, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WHERE A FRACTURED FEMORAL COMPONENT WAS IDENTIFIED ON X-RAY. THE PATIENT UNDERWENT A REVISION SURGERY; DURING WHICH, THE FRACTURED FEMORAL COMPONENT WAS CONFIRMED. ALL INITIAL IMPLANTS WERE REPLACED WITH TOTAL KNEE ARTHROPLASTY COMPONENTS WITHOUT COMPLICATION. 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
    81244 OXFORD UNI TWIN-PEG FEMORAL MD OXFORD CEMENTED FEMORALS NRA BIOMET UK LTD. N/A J3953454 05019279132478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10 NARRATIVE.