BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

    MDR report key: 10860816 · Received November 18, 2020

    Report

    Report Number
    3005180920-2020-00803
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 19, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 OCTOBER 2020: LOT 178259: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2018. EXPIRATION DATE: 2023-03-20. 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: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 178993. BATCH REVIEW PERFORMED ON 29 OCTOBER 2020: LOT 178993: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2017. EXPIRATION DATE: 2022-11-23. 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: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 174521. BATCH REVIEW PERFORMED ON 18 NOVEMBER 2020: LOT 174521: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2017. EXPIRATION DATE: 2022-11-23. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING PSOAS TENDONITIS. THE CAUSE OF THE PSOAS TENDONITIS IS UNKNOWN. 2 YEARS AND 5 MONTHS AFTER THE PRIMARY THE SURGEON REVISED THE ACETABULAR COMPONENTS AND THE CERAMIC HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323341 CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150DH 178259 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention