BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 18364400 · Received December 20, 2023

    Report

    Report Number
    3005180920-2023-01047
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-DEC-2023: LOT 2105762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2021. EXPIRATION DATE: 2026-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 143 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED. BATCH REVIEW PERFORMED ON 13-DEC-2023: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER 36/E (K103721) LOT 2107100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2021. EXPIRATION DATE: 2026-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 151 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0 (K112115) LOT 2111077: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW STEM: M-VIZION 01.22.001 PROXIMAL BODY Ø20MM L 40MM STD (K170690) LOT 155506A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2021. EXPIRATION DATE: 2026-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. ON (B)(6) 2022, THE SURGEON REVISED THE STEM AND HEAD SUCCESSFULLY. PRESENTLY, THE PATIENT CAME IN SUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, LINER, HEAD AND PROXIMAL BODY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110605 MPACT ACETABULAR SHELL Ø54 TWO-HOLES HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 2105762 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention