BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DME

    MDR report key: 20237350 · Received September 17, 2024

    Report

    Report Number
    3005180920-2024-00739
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 AUGUST 2024 LOT 2317941: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2023. EXPIRATION DATE: 2028-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT BATCH REVIEW PERFORMED ON 27 AUGUST 2024 LINER: MPACT DM 01.32.4248CF DM CONVERTER TIN COATED F/DME (K211891) LOT. 2307817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AGO-2023. EXPIRATION DATE: 2028-07-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024 (THREE MONTHS AFTER LAST REVISION), THE HAD PAIN DUE TO A DISLOCATION OF THE LINER FROM THE DM CONVERTER LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE COCR DIDN'T DISLOCATE FROM THE DM LINER. THE DM CONVERTER DIDN'T DISLOCATE FROM THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760153 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DME HIP ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 2317941 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention