BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

    MDR report key: 13631290 · Received March 1, 2022

    Report

    Report Number
    3005180920-2022-00151
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810862
    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 09 FEBRUARY 2022: LOT 2100555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 2026-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.4248MC DM CONVERTER LINER F/DME (K131458) LOT. 2010074. BATCH REVIEW PERFORMED ON 09 FEBRUARY 2022: LOT 2010074: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2021. EXPIRATION DATE: 2026-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 172252. BATCH REVIEW PERFORMED ON 09 FEBRUARY 2022: LOT 172252: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2017. EXPIRATION DATE: 2022-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: QUADRA-P 01.12.182 QUADRA-P COLLARED LAT STEM SIEZ 2 (K192827) LOT. 2102698. BATCH REVIEW PERFORMED ON 09 FEBRUARY 2022: LOT 2102698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JULY-. EXPIRATION DATE: 2026-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265) LOT. 2102557. BATCH REVIEW PERFORMED ON 09 FEBRUARY 2022: LOT 2102557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2021. EXPIRATION DATE: 2026-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AND A HALF AFTER PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992614 CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.156MH 2100555 07630030810862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention