BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/C

    MDR report key: 12224595 · Received July 26, 2021

    Report

    Report Number
    3005180920-2021-00636
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 9, 2021
    Report Date
    July 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811845
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 JULY 2021: LOT 1900216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2019. EXPIRATION DATE: 2024-MARCH-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: 2. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 189641 K112115. BATCH REVIEW PERFORMED ON 21 JULY 2021: LOT 189641: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-FEB-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO SUSPICION OF STEM MOBILIZATION. PRE-REVISION X-RAYS SUGGESTED STEM MOBILIZATION. DURING THE SURGERY, IT WAS CONFIRMED THAT THE STEM WAS WELL FIXED AND THE SURGEON PUT SOME BONE CHIPS DOWN THE STEM (THE REASON IS UNKNOWN) AND REPLACED THE HEAD AND LINER DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121950 LINER: MPACT FLAT PE HC LINER 32/C HIP LINER LPH MEDACTA INTERNATIONAL SA 01.32.3239HCT 01.32.3239HCT 07630030811845

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention