BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 8607925 · Received May 14, 2019

    Report

    Report Number
    3005180920-2019-00371
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 14, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    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 13 MAY 2019 LOT 185430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-28. 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 IMPLANTS INVOLVED: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721), LOT 186972: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2018. EXPIRATION DATE: 2023-10-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (COMPLAINT 0707-19). STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM # 7 (K151531), LOT 186730: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2018. EXPIRATION DATE: 2023-11-13. 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. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115), LOT 186550: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2018. EXPIRATION DATE: 2023-11-18. 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

    ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, THE LINER, THE HEAD AND THE STEM WITH ANOTHER COMPANY'S PRODUCTS FOR A HIP INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400219 CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES ACETABULAR SHELL CEMENTLESS LPH MEDACTA INTERNATIONAL SA 185430 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention