BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P STD SIZE 2

    MDR report key: 11862763 · Received May 21, 2021

    Report

    Report Number
    3005180920-2021-00407
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720014
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 MAY 2021: LOT 182522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2018. EXPIRATION DATE: 2023-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 03 MAY 2021: LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø 36 / E (K103352) LOT 147767: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115)LOT 1900802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAG-2019. EXPIRATION DATE: 2024-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE PATIENT'S OPERATED LEG WAS LONGER THAN THEN NON-OPERATED LEG. THE PATIENT HAD PELVIC OBLIQUITY ISSUES AND ON X-RAYS THE LEGS LOOKED EQUAL, BUT CLINICALLY THE PATIENT WAS LONG ON THE OPERATED SIDE. 1 YEAR AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE PATIENT STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761060 STEM: AMISTEM P STD SIZE 2 FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 182522 07630040720014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention