BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E

    MDR report key: 13469560 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00070
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 10, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807572
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 JANUARY 2022. LOT 2111760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2021. EXPIRATION DATE: 2026-SEP-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, FEW WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 JANUARY 2022: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2101454 LOT 2101454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 JANUARY 2022. LOT 2111760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2021. EXPIRATION DATE: 2026-SEP-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, FEW WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 JANUARY 2022: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2101454 LOT 2101454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    INFECTION AFTER WOUND HEALING DISORDER. HEAD AND LINER REVISED 2 MONTHS AFTER THE PRIMARY SURGERY.

    Description of Event or Problem · 0

    INFECTION AFTER WOUND HEALING DISORDER. HEAD AND LINER REVISED 2 MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487078 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E FLAT PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.26.3244HCT 2111760 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention