BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 8909371 · Received August 20, 2019

    Report

    Report Number
    3005180920-2019-00692
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    July 22, 2019
    Report Date
    April 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD PERMANENT HARDWARE IMPLANTED ON (B)(6) 2020, ABOUT 7MONTHS AFTER THE REVISION SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 2-AUGUST-2019: LOT 174500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2017. EXPIRATION DATE: 2022-12-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT ADDITIONAL IMPLANT INVOLVED: SCREWS: MPACT 01.32.6545 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 45 (K103721), LOT. 115668D. BATCH REVIEW PERFORMED ON 2-AUGUST-2019: LOT 115668D: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-"OTT"-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 SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721), LOT. 180584. BATCH REVIEW PERFORMED ON 2-AUGUST-2019: LOT 180584: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2018. EXPIRATION DATE: 2023-03-08. 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 IMPLANT INVOLVED: LINER: MPACT 01.32.3244HCT FLAT PE HC LINER Ø32/E (K103721), LOT. 174522. BATCH REVIEW PERFORMED ON 2-AUGUST-2019: LOT 174522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2017. EXPIRATION DATE: 2022-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: SCREWS: STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3 (K093944), LOT. 180005. BATCH REVIEW PERFORMED ON 2-AUGUST-2019: LOT 180005: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2018. EXPIRATION DATE: 2023-05-21. 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 IMPLANT INVOLVED: BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 (K072857), LOT. 178436. BATCH REVIEW PERFORMED ON 2-AUGUST-2019: LOT 178436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-03-07. 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

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 1 MONTH FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS STAPHYLOCOCCUS AUREUS. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706481 MPACT ACETABULAR SHELL Ø52 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.152DH 174500 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention