BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE

    MDR report key: 13947487 · Received March 30, 2022

    Report

    Report Number
    3005180920-2022-00207
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810787
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MARCH 2022: LOT 2106822: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JULY-2021. EXPIRATION DATE: 2026-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2108135. BATCH REVIEW PERFORMED ON 08 MARCH 2022: LOT 2108135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2021. EXPIRATION DATE: 2026-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: QUADRA-P 01.12.254 QUADRA-P SHORT NECK STD STEM SIZE 4 (K192827) LOT. 2004666. BATCH REVIEW PERFORMED ON 08 MARCH 2022: LOT 2004666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEPT-2020. EXPIRATION DATE: 2025-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2105978. BATCH REVIEW PERFORMED ON 08 MARCH 2022: LOT 2105978: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEPT-2021. EXPIRATION DATE: 2026-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 4 MONTHS FROM PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782525 CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150SH 2106822 07630030810787

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention