BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

    MDR report key: 12258956 · Received August 2, 2021

    Report

    Report Number
    3005180920-2021-00658
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 19, 2021
    Report Date
    August 2, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JULY 2021: LOT 2010311: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2021. EXPIRATION DATE: 2026-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 28 JULY 2021: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 2100154: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2021. EXPIRATION DATE: 2026-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6535 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 (K103721) LOT 2013780: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2021. EXPIRATION DATE: 2026-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: QUADRA -R 01.12.065 CEMENTLESS, HA COATED REVISION STEM SIZE 5 (K082792) LOT 1810350: (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 WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 1 MONTH AFTER PRIMARY DUE TO INFECTION. STAPH EPIDERMIS WAS THE PATHOGEN. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL IMPLANT REVISED SUCCESSFULLY AND TIBIAL SPACER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160884 CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.150DH 2010311 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention