BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES

    MDR report key: 10535329 · Received September 15, 2020

    Report

    Report Number
    3005180920-2020-00606
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2020: LOT 1907399: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. CLINICAL EVALUATION: INFECTION IN HYBRID THA OCCURRED AFTER REPEATED SURGERIES IN A (B)(6) YEAR-OLD WOMAN. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. OTHER DEVICES INVOLVED IN THE EVENT: SCREWS: MPACT 01.32.6535 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 LOT. 1905815 (K103721). BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2020: LOT 1905815: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2019. EXPIRATION DATE: 2024-07-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E LOT. 1905500 (K103721). BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2020: LOT 1905500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. STEM: QUADRA -R 01.12.062 CEMENTLESS, HA COATED REVISION STEM # 2 LOT. 1905457 (K082792). BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2020: LOT 1905457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. EXPIRATION DATE: 2025-01-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL +8 LOT. 1907363 (K112115). BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2020: LOT 1907363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT HAD A SURGERY IN (B)(6) 2020 DUE TO FEMUR FRACTURE, FIXED WITHOUT USING MEDACTA IMPLANTS. ON (B)(6) 2020 THE PATIENT WAS REVISED TO CONVERT THE FRACTURE FIXATION IN A THA, MEDACTA IMPLANTS WERE USED. ON (B)(6) 2020 THE PATIENT HAS BEEN REVISED DUE TO INFECTION. ALL DEVICES REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999413 CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152DH 1907399 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention