BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

    MDR report key: 9376095 · Received November 26, 2019

    Report

    Report Number
    3005180920-2019-00995
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 30, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810800
    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 11 NOVEMBER 2019: LOT 1900203: 50 ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2019. EXPIRATION DATE: 2024-05-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 11 NOVEMBER 2019 SCREWS: IMPACT 01.32.6535 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 (K103721) LOT. 185348 LOT 185348: 110 ITEMS MANUFACTURED AND RELEASED ON 20-JULY-2018. EXPIRATION DATE: 2023-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: IMPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT. 1900967 LOT 1900967: 200 ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 150 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: IMPACT 01.32.3644HCAT HOODED PE HC LINER Ø36/E (K132879) LOT. 1810227. LOT 1810227: 50 ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2018. EXPIRATION DATE: 2023-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 34 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: IMPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT. 1902135 LOT 1902135: 450 ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 304 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: AMISTEM P 01.18.403 AMISTEM-P STD STEM SIZE 3 (K173794) LOT. 180727. LOT 180727: 180 ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 165 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 (K080885) LOT. 147314. LOT 147314: 100 ITEMS MANUFACTURED AND RELEASED ON 3-MAR-2015. EXPIRATION DATE: 2023-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 89 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    WASHOUT PERFORMED AFTER 2 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND DID NOT EXPLANT ANY IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170662 CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1900203 07630030810800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention