BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED STD STEM SIZE 6

    MDR report key: 19850730 · Received July 29, 2024

    Report

    Report Number
    3005180920-2024-00571
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JULY 2024: LOT 2009303: (B)(4) MANUFACTURED AND RELEASED ON 20-NOV-2020. EXPIRATION DATE: 2025-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265) LOT 2315929: (B)(4) MANUFACTURED AND RELEASED ON 19-SEP-2023. EXPIRATION DATE: 2028-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2118284: (B)(4) MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2027-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT DM 01.32.4248CF DM CONVERTER TIN COATED F/DME (K211891) LOT 2217487: (B)(4) MANUFACTURED AND RELEASED ON 02-DEC-2022. EXPIRATION DATE: 2027-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.356MH ACETABULAR SHELL Ø56 MULTI-HOLE THIN (K202568) LOT 2208154: (B)(4) MANUFACTURED AND RELEASED ON 27-GIU-2022. EXPIRATION DATE: 2027-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0015 CANCELLOUS BONE SCREW Ø 6,5 L 15 (K200391) LOT 2239066: (B)(4) MANUFACTURED AND RELEASED ON 25-OCT-2022. EXPIRATION DATE: 2027-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0015 CANCELLOUS BONE SCREW Ø 6,5 L 15 (K200391) LOT 2306686: (B)(4) MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT 2218862: (B)(4) MANUFACTURED AND RELEASED ON 12-DEC-2022. EXPIRATION DATE: 2027-11-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0045 CANCELLOUS BONE SCREW Ø 6,5 L 45 (K200391) LOT 2119577: (B)(4) MANUFACTURED AND RELEASED ON 05-JULY-2022. EXPIRATION DATE: 2017-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 AN HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 MONTHS FROM PRIMARY 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
    950970 AMISTEM-P COLLARED STD STEM SIZE 6 HIP STEM LZO MEDACTA INTERNATIONAL SA 2009303

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention