BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES

    MDR report key: 15692444 · Received October 28, 2022

    Report

    Report Number
    3005180920-2022-00798
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810732
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 OCTOBER 2022 ON LOT 2117774: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2022. EXPIRATION DATE: 2027-MAR-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS BATCH REVIEW PERFORMED ON 10 OCTOBER 2022 ON LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT 2118342: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2022. EXPIRATION DATE: 2027-JAN-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 10 OCTOBER 2022 ON STEM: SMS SOLID 01.36.162 SMS COLLARED SOLID STEM LAT SIZE 2 (K203041) LOT 2102620: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2021. EXPIRATION DATE: 2026-JUN-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 10 OCTOBER 2022 ON BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 2119452: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2022. EXPIRATION DATE: 2027-MAR-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871983 CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.148DH 2117774 07630030810732

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention