BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-P QUADRA-P STD STEM SIZE 2

    MDR report key: 19339180 · Received May 17, 2024

    Report

    Report Number
    3005180920-2024-00323
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 20, 2024
    Report Date
    May 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720434
    PMA / PMN Number
    K181254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 APRIL 2024: LOT 2339148: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2023. EXPIRATION DATE: 2028-NOV-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: REVISION 4 DAYS AFTER THE PRIMARY THA SURGERY DUE TO THE INCREASED POSTOPERATIVE LENGTH OF THE LEG. THIS IS NOT A DEFECT THE PRODUCT IMPLANTED BUT A TECHNICAL ERROR DURING SURGERY. ADDITIONAL DETAILS, BATCH REVIEW PERFORMED ON 26 APRIL 2024: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2340135 LOT 2340135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2023. EXPIRATION DATE: 2028-OCT-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: CC E CC LIGHT 01.26.3239HCT FLAT PE HC LINER Ø 32 / C (K120531) LOT. 2303230 LOT 2303230: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2023. EXPIRATION DATE: 2028-MAR-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP CC TRIO 01.26.45.1146 ACETABULAR SHELL CC TRIO NO-HOLE Ø46 (K122911) LOT. 2216281 LOT 2216281: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-SEP-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 4 DAYS AFTER THE PRIMARY SURGERY DUE TO THE INCREASED POSTOPERATIVE LENGTH OF THE LEG. A SMALLER SIZED CEMENTED STEM HAS BEEN IMPLANTED WITH A DOUBLE MOBILITY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535770 STEM: QUADRA-P QUADRA-P STD STEM SIZE 2 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2339148 07630040720434

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention