BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 8955359 · Received September 3, 2019

    Report

    Report Number
    3005180920-2019-00748
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    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 20 AUGUST 2019: LOT 181124: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2018. EXPIRATION DATE: 2023-06-04. 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. 165918. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 165918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2016. EXPIRATION DATE: 2021-10-23. 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: SCREWS: MPACT 01.32.6545 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 (K103721) L 45, LOT. 172445. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 172445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2017. EXPIRATION DATE: 2022-04-25. 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 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721), LOT. 173318. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 173318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEPT-2017. EXPIRATION DATE: 2022-08-17. 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: STEM: AMISTEM P 01.18.405 AMISTEM-P STD STEM SIZE 5 (K173794), LOT. 180732. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 180732: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-GIU-2018. EXPIRATION DATE: 2023-06-06. 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 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115), LOT. 187085. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 187085: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-12-03. 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

    ABOUT 1 MONTH AND A HALF AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT HIP FOR INFECTION. THE PATHOGEN IS UNKNOWN, ALL IMPLANTS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749571 CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 181124 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention