BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN OXFORD TIBIA

    MDR report key: 19973510 · Received August 13, 2024

    Report

    Report Number
    0009613350-2024-00359
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    January 12, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINATE THIS MDR WAS NOT FILED UNDER THE CORRECT MFR NUMBER. THIS EVENT WILL BE REPORTED UNDER MFR NUMBER (B)(4) (UK).

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN FEMORAL COMPONENT, UNKNOWN LOT AND ITEM#; UNKNOWN BEARING, UNKNOWN LOT AND ITEM#. G2: FOREIGN: GERMANY. LITERATURE: JULIUS WATRINET, PHILIPP BLUM, MICHAEL MAIER,STEFEN KLINGBEIL,STEPHAN REGENBOGEN,PETER AUGAT,ROLF SCHIPP,WOLFGANG RENG (2024) UNDERSIZING OF THE TIBIAL COMPONENT IN OXFORD UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) INCREASES THE RISK OF PERIPROSTHETIC FRACTURES. ARCH ORTHOP TRAUMA SURG 144, 1353¿1359 (2024). HTTPS://DOI.ORG/10.1007/S00402-023-05142-Z. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINATE THIS MDR WAS NOT FILED UNDER THE CORRECT MFR NUMBER. THIS EVENT WILL BE REPORTED UNDER MFR NUMBER (B)(4) (UK).

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT PART OF THE CEMENTLESS GROUP EXPERIENCED A TIBIAL PERIPROSTHETIC FRACTURE ON DAY 36 POST-OP WITHOUT IMPLANT MISMATCH SIZE S FEMORAL/A TIBIAL COMPONENTS. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620123 UNKNOWN OXFORD TIBIA OXFORD KNEE IMPLANT HRY ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R SEE H11 NARRATIVE