BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 9652067 · Received January 31, 2020

    Report

    Report Number
    3005180920-2020-00028
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 31, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JANUARY 2020. LOT 1900179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 1904642. BATCH REVIEW PERFORMED ON 20 JANUARY 2020. LOT 1904642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2019. EXPIRATION DATE: 2024-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: IMPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 1900217. BATCH REVIEW PERFORMED ON 20 JANUARY 2020. LOT 1900217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2019. EXPIRATION DATE: 2024-04-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY IN THE HIP. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED, 2 WEEKS AFTER PRIMARY SURGERY, THE HEAD, CUP, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118078 CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150DH 1900179 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention