BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 8527543 · Received April 18, 2019

    Report

    Report Number
    3005180920-2019-00292
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    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 16 APRIL 2019: LOT 186863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2019. EXPIRATION DATE: 2023-12-12. 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. OTHER DEVICES WERE INVOLVED IN THE COMPLAINT LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E LOT 186969 (K103721): 154 ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2018. EXPIRATION DATE: 2023-10-17. 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. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 LOT 180544 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2018. EXPIRATION DATE: 2023-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANTHER SIMILAR REPORTED EVENT (COMPLAINT (B)(4), MDR 2018-00981). STEM: AMISTEM P 01.18.434 AMISTEM-P COLLARED STD STEM #4 LOT 178147 (K173794): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2018. EXPIRATION DATE: 2023-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 1 MONTH POST PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION CASE. WASH OUT AND ALL IMPLANTS SWAP. THE PATHOGEN IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319494 CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 186863 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention