BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø48 TWO-HOLES

    MDR report key: 16378891 · Received February 15, 2023

    Report

    Report Number
    3005180920-2023-00080
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810732
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-JAN-2023. LOT 2214622: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-09-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 30-JAN-2023: LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/CC (K103721) LOT 2219354: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2022. EXPIRATION DATE: 2027-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT 2119459: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2022. EXPIRATION DATE: 2027-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY DUE TO THE DISLOCATION OF THE HEAD FROM THE LINER. DURING THE REVISION, THE CUP WAS FOUND TO BE LOOSE. IT IS LIKELY THAT THE LOOSENESS OF THE CUP CAUSED THE JOINT LUXATION. CUP, HEAD, LINER, AND STEM REVISED SUCCESSFULLY. THE STEM WAS REVISED ONLY TO BE ABLE TO REVISE THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927888 MPACT ACETABULAR SHELL Ø48 TWO-HOLES HIP CEMENTLESS CUP LPH MEDACTA INTERNATIONAL SA 01.32.148DH 2214622 07630030810732

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention