BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES

    MDR report key: 10612281 · Received October 1, 2020

    Report

    Report Number
    3005180920-2020-00662
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    April 5, 2018
    Report Date
    October 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2020: LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2017. EXPIRATION DATE: 2022-09-24. 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 01.32.3244HCAT HOODED PE HC LINER Ø32/E (K132879) LOT. 160915. BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2020: LOT 160915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2016. EXPIRATION DATE: 2021-03-08. 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 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 173291. BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2020: LOT 173291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2017. EXPIRATION DATE: 2022-08-27. 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: STEM: QUADRA-H 01.12.23SN CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK (K082792) LOT. 163273. BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2020: LOT 163273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2016. EXPIRATION DATE: 2021-07-26. 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

    REVISION SURGERY PERFORMED, 1 MONTH AFTER PRIMARY SURGERY, DUE TO INFECTION. RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078134 CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.152DH 172585 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention