BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/D

    MDR report key: 8424796 · Received March 15, 2019

    Report

    Report Number
    3005180920-2019-00148
    Event Type
    Injury
    Date Received
    March 15, 2019
    Date of Event
    February 12, 2019
    Report Date
    March 15, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED BY MEDACTA USA ASSOCIATE QUALITY SYSTEMS ENGINEER ON THE 14 MARCH 2019 (HE RECEIVED THE INFORMATION BY THE SALES AGENT): THE SURGEON CONFIRMED THAT THE DISLOCATION OCCURRED DUE TO AN EXCESSIVE ANTEVERTED CUP. THE REASON FOR THE CUP BEING ANTEVERTED WAS DUE TO THE PATIENT'S SPINE BEING FUSED FROM A PREVIOUS SPINAL SURGERY. IT WAS CONFIRMED THAT MEDACTA LINER AND HEAD WERE REVISED WITH COMPETITOR'S PRODUCTS, THE CUP HAS BEEN LEFT IN SITU. BATCH REVIEW PERFORMED ON 12 MARCH 2019: LOT 184750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2018. EXPIRATION DATE: 2023-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115), LOT. 185168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-10-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN AMIS PRIMARY HIP SURGERY ON (B)(6) 2019 AND SUBSEQUENTLY THE HEAD DISLOCATED ANTERIORLY FROM THE LINER. THE SURGEON REVISED, ON THE SAME DAY, THE HEAD AND LINER WITH COMPETITOR 'S PRODUCTS. THE 32MM BIOLOX HEAD HAS BEEN REPLACED WITH A 28MM COCR HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217295 LINER: MPACT FLAT PE HC LINER Ø32/D HIP FLAT LINER LPH MEDACTA INTERNATIONAL SA 184750 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention