BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 18659378 · Received February 7, 2024

    Report

    Report Number
    3005180920-2024-00029
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 10, 2024
    Report Date
    February 7, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 JANUARY 2024: LOT 2310977: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2023. EXPIRATION DATE: 2028-JUN-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 22 JANUARY 2024: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2310826. LOT 2310826: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2023. EXPIRATION DATE: 2028-MAY-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: AMISTEM P 01.18.404 AMISTEM-P STD STEM SIZE 4 (K173794) LOT. 2239293. LOT 2239293: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2023. EXPIRATION DATE: 2027-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.154MH ACETABULAR SHELL Ø54 MULTI-HOLE (K132879) LOT. 2243245. LOT 2243245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2023. EXPIRATION DATE: 2028-APR-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907603 LINER: MPACT FLAT PE HC LINER Ø36/E MPACT HC LINER LPH MEDACTA INTERNATIONAL SA 2310977 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention