BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 NO-HOLE

    MDR report key: 8573535 · Received May 2, 2019

    Report

    Report Number
    3005180920-2019-00330
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810817
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 APR 2019: LOT 184599: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2018. EXPIRATION DATE: 2023-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: LINER: MPACT 01.32.3244HCT FLAT PE HC LINER Ø32/E (K103721), LOT 186965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2018. EXPIRATION DATE: 2023-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. STEM: AMISTEM P 01.18.414 AMISTEM-P LAT STEM SIZE 4 (K173794), LOT 179949: 139 ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2018. EXPIRATION DATE: 2023-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.231H HEAD BIOLOX OPTION Ø 32 (K131518) [IMPLANTED ON (B)(6) 2019, DURING THE FIRST REVISION REPORTED IN THE MDR 2019-00290]. LOT 186574: (B)(4) ITEMS; MANUFACTURED AND RELEASED ON 12-NOV-2018. EXPIRATION DATE: 2023-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.241A SLEEVE SIZE M (K131518) [IMPLANTED ON (B)(6) 2019, DURING THE FIRST REVISION REPORTED IN THE MDR 2019-00290]. LOT 183383: (B)(4); ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2018. EXPIRATION DATE: 2023-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 13 DAYS AFTER THE PREVIOUS REVISION (PERFORMED WASHOUT AND HEAD REVISION ALSO DUE TO AN INFECTION, MDR 2019-00290) DUE TO AN INFECTION (THE PATHOGEN HAS BEEN IDENTIFIED AS STAPHYLOCOCCUS). THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD, LINER, AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY CASE WAS PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367768 CUP: MPACT ACETABULAR SHELL Ø52 NO-HOLE CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 184599 07630030810817

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention