BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 20351567 · Received October 2, 2024

    Report

    Report Number
    3005180920-2024-00801
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630345798749
    PMA / PMN Number
    K230011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024. LOT 2339116: 31 ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2024. EXPIRATION DATE: 2029-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024 OTHER: SCREWS 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT 2348349: 46 ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2024. EXPIRATION DATE: 2029-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024 STEM: QUADRA-P 01.12.163 QUADRA-P COLLARED STD. SIZE 3 (K192827) LOT 2339116: 28 ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024 BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 (K131518) LOT 2348075: 50 ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2024. EXPIRATION DATE: 2028-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024 LINER: MPACT 01.32.3644HCAT HOODED PE HC LINER Ø36/E (K132879) LOT 2248469: 72 ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2023. EXPIRATION DATE: 2028-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 66 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. SUBSEQUENTLY. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER ON (B)(6) 2024. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE SCREW, CUP, LINER, HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915699 MPACT ACETABULAR SYSTEM HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150DHT 2339116 07630345798749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention