BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES

    MDR report key: 15368483 · Received September 7, 2022

    Report

    Report Number
    3005180920-2022-00676
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 10, 2022
    Report Date
    March 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810930
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-AUG-2022. LOT 2111424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2021. EXPIRATION DATE: 2026-11-09. 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 COMPONENTS INVOLVED: LINER: MPACT 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT 2116168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. EXPIRATION DATE: 2026-12-13. 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. STEM: SMS SOLID 01.36.151 SMS COLLARED SOLID STEM STD SIZE 11 (K203041) LOT 2103767: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2021. EXPIRATION DATE: 2026-07-21. 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 01.29.214 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L + 4 (K112115) LOT 2111117: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2021. EXPIRATION DATE: 2026-11-16. 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. SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT 2109277: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2021. EXPIRATION DATE: 2026-10-25. 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 Manufacturer Narrative · 0

    PERMANENT HARDWARE WAS IMPLANTED IN THIS PATIENT ON (B)(6) 2023.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486517 CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES HIP ACETABULAR CUP CEMENTLESS LPH MEDACTA INTERNATIONAL SA 01.32.160DH 2111424 07630030810930

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention