BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

    MDR report key: 11047211 · Received December 21, 2020

    Report

    Report Number
    3005180920-2020-00934
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 NOVEMBER 2020: LOT 1908320: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-12-02. 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: MECTACER 01.29.231H HEAD BIOLOX OPTION Ø 32 (K131518) LOT. 170727. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2020: LOT 170727: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2017. EXPIRATION DATE: 2022-08-15. 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: MECTACER 01.29.241A SLEEVE SIZE M (K131518) LOT. 187108: BATCH REVIEW PERFORMED ON 28 NOVEMBER 2020: LOT 187108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-11-27. 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 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 1908277. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2020: LOT 1908277: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2019. EXPIRATION DATE: 2024-10-05. 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: SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT. 157802. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2020: LOT 157802:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2016. EXPIRATION DATE: 2021-02-20. 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: SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT. 161076. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2020: LOT 161076: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2016. EXPIRATION DATE: 2021-04-19. 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: STEM: QUADRA-H 01.12.22SN CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK (K082792) LOT. 188790. BATCH REVIEW PERFORMED ON 18 DECEMBER 2020: LOT 188790: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2019. EXPIRATION DATE: 2024-01-20. 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

    22 DAYS AFTER PRIMARY SURGERY, THE PATIENT WAS DIAGNOSED WITH INFECTION AND ALL THE IMPLANTS HAVE BEEN REMOVED. A CEMENT SPACER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515222 CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150DH 1908320 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention