BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø40/G

    MDR report key: 8924581 · Received August 23, 2019

    Report

    Report Number
    3005180920-2019-00702
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812286
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31-JULY-2019: LOT 166672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2016. EXPIRATION DATE: 2021-11-10. 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 IN THE EVENT, BATCH REVIEW PERFORMED ON 31-JULY-2019. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT. 167232. LOT 167232: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2016. EXPIRATION DATE: 2021-11-21. 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. SCREWS: MPACT 01.32.6540 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40 (K103721) LOT. 172444. LOT 172444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2017. EXPIRATION DATE: 2022-08-17. 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. CUP: MPACT 01.32.160DH ACETABULAR SHELL Ø60 TWO-HOLES (K132879) LOT. 161861. LOT 161861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-SEPT-2016. EXPIRATION DATE: 2021-09-05. 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. MPACT 01.31.55TP SHELL SCREW PLUG (K103721) LOT. 175555. LOT 175555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2017. EXPIRATION DATE: 2022-07-06. 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. BALL HEADS: MECTACER 01.29.214 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L + 4 (K112115) LOT. 162740. LOT 162740: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2016. EXPIRATION DATE: 2021-07-19. 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. STEM: MINIMAX 01.13.106L CEMENTLESS ANATOMICAL STEM LEFT SIZE 6 (K170845) LOT. 169038; LOT 169038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2017. EXPIRATION DATE: 2022-05-01. 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. SCREWS: MPACT 01.32.6545 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 45 (K103721) LOT. 165280. LOT 165280: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2016. EXPIRATION DATE: 2021-09-25. 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. THE SURGEON REMOVED ALL HARDWARE AND PUT IN AN ANTIBIOTIC SPACER 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719312 LINER: MPACT FLAT PE HC LINER Ø40/G FLAT PE HC LINER LZO MEDACTA INTERNATIONAL SA 166672 07630030812286

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention