BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 8953726 · Received September 2, 2019

    Report

    Report Number
    3005180920-2019-00744
    Event Type
    Injury
    Date Received
    September 2, 2019
    Date of Event
    August 16, 2019
    Report Date
    September 2, 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 20 AUGUST 2019: LOT 172587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2017. EXPIRATION DATE: 2022-10-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721), LOT. 174525. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 174525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2017. EXPIRATION DATE: 2022-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721), LOT. 175082. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 175082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2017. EXPIRATION DATE: 2022-10-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721), LOT. 175731. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 175731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2018. EXPIRATION DATE: 2022-10-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3 (K093944), LOT. 175917. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 175917: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2018. EXPIRATION DATE: 2023-01-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115), LOT. 174721. BATCH REVIEW PERFORMED ON 20 AUGUST 2019: LOT 174721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2017. EXPIRATION DATE: 2022-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ON (B)(6) 2019 WE WERE INFORMED THAT THE SURGEON WOULD HAVE REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER ON (B)(6) 2019 (1 YEAR AND 5 MONTHS AFTER PRIMARY). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747855 CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 172587 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention