BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35

    MDR report key: 9646641 · Received January 30, 2020

    Report

    Report Number
    3005180920-2020-00010
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812408
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 JANUARY 2020: LOT 1706505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2017. EXPIRATION DATE: 2022-03-05. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 07 JANUARY 2020. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD 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 WITH ANOTHER SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6535 CANCELLOUS BONE SCREW, FLAT HEAD 6,5 L 35 (K103721) LOT. 168797 LOT 168797: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2017. EXPIRATION DATE: 2022-01-25. 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. CUP: MPACT 01.32.156MH ACETABULAR SHELL 56 MULTI-HOLE (K1328799) LOT. 173224 LOT 173224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-SEP-2017. EXPIRATION DATE: 2022-08-18. 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. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER 36/F (K103721) LOT. 171741 LOT 171741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-09-03. 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. BALL HEADS: COCR 01.25.034 COCR BALL HEAD 12/14 36 SIZE XXL +10.5 (K080885) LOT. 162376 LOT 162376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-07-10. 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. STEM: AMISTEM H 01.18.133 HA COATED STD STEM #3 (K093944) LOT. 165812 LOT 165812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2017. EXPIRATION DATE: 2021-12-14. 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 IMPLANTED AN ANTIBIOTIC SPACER 1 YEAR AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109656 SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 LPH MEDACTA INTERNATIONAL SA 01.32.6535 170650 07630030812408

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention