BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/E

    MDR report key: 10301344 · Received July 21, 2020

    Report

    Report Number
    3005180920-2020-00444
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 27, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 JULY 2020: LOT 188901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 LOT. 1810819 (K131518). BATCH REVIEW PERFORMED ON 01 JULY 2020: LOT 1810819: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-14. 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. BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL LOT. 184409 (K131518). BATCH REVIEW PERFORMED ON 01 JULY 2020: LOT 184409: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-09-02. 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. ON (B)(6) 2020, THE SURGEON REVISED THE HEAD. PRESENTLY (22 DAYS AFTER PREVIOUS SURGERY), THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, OPTION SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767343 LINER: MPACT FLAT PE HC LINER 36/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 188901 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention