BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 13557377 · Received February 18, 2022

    Report

    Report Number
    3005180920-2022-00137
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    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 02 FEBRUARY 2022: LOT 188867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-18. 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: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2000178. BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: LOT 2000178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2020. EXPIRATION DATE: 2025-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM P 01.18.402 AMISTEM-P STD STEM SIZE 2 (K173794) LOT. 2000050. BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: LOT 2000050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2020. EXPIRATION DATE: 2025-04-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 1904642. BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: LOT 1904642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2019. EXPIRATION DATE: 2024-09-09. 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: SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT. 2002265. BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: LOT 2002265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2020. EXPIRATION DATE: 2025-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 9 MONTHS AFTER THE PRIMARY SURGERY 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
    473014 CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150DH 188867 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention