BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE

    MDR report key: 11481913 · Received March 15, 2021

    Report

    Report Number
    3005180920-2021-00214
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810862
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 MARCH 2021: LOT 1910276: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 1910290. BATCH REVIEW PERFORMED 02 MARCH 2021: LOT 1910290: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2024-12-15, NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT. 2002265. BATCH REVIEW PERFORMED 02 MARCH 2021: 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 ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM C 01.18.102 CEMENTED LAT STEM SIZE 2 (K103189) LOT. 2000006. BATCH REVIEW PERFORMED 02 MARCH 2021: LOT 2000006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 2025-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.033 COCR BALL HEAD 12/14 Ø 36 SIZE XL +7 (K080885) LOT. 171785. BATCH REVIEW PERFORMED 02 MARCH 2021: LOT 171785: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2017. EXPIRATION DATE: 2022-07-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 6 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382296 CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.156MH 1910276 07630030810862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention