BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1

    MDR report key: 10349975 · Received July 31, 2020

    Report

    Report Number
    3005180920-2020-00481
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720205
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 JULY 2020: LOT 1905031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2019. EXPIRATION DATE: 27-AUG-2024. 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. OTHER DEVICES INVOLVED ON THE EVENT: CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES LOT. 1907398 (K132879). BATCH REVIEW PERFORMED ON 23 JULY 2020: LOT 1907398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 24-NOV-2024. 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 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 1907346 (K112115). BATCH REVIEW PERFORMED ON 23 JULY 2020: LOT 1907346: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. EXPIRATION DATE: 2025-01-08. 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. SAME PATIENT, THE SAME LOT WAS USED IN THE FIRST REVISION SURGERY. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D LOT. 1905497 (K103721). BATCH REVIEW PERFORMED ON 23 JULY 2020: LOT 1905497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 15-JUN-2024. 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 HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON 18 JUNE 2020, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813656 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1905031 07630040720205

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention