BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 4

    MDR report key: 14369186 · Received May 12, 2022

    Report

    Report Number
    3005180920-2022-00361
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804205
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 APRIL 2022. LOT 131562: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2013. EXPIRATION DATE: 2018-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS IT IS EVALUATED THAT AROUND PROXIMAL HALF OF THE STEM BODY IS COVERED WITH HA COATING. THIS MEANS THAT THE STEM WAS NOT CORRECTLY OSSEOINTEGRATED WITH THE PATIENT'S BONE. SOME RESIDUALS OF BONE FRAGMENTS ARE PRESENT ON THE STEM BODY MICROSTRUCTURES. ADDITIONALLY, SOME SIGNS AND SCRATCHES TOGETHER WITH BURNS ARE PRESENT ON THE STEM BODY PROBABLY DUE TO REVISION SURGERY. REGARDING THE LINER, NO PARTICULAR SIGNS RELATED TO THE EVENT WERE NOTICED. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FROM THE RECEIVED INFORMATION. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 APRIL 2022: LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 (K092265) LOT. 131722 LOT 131722: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2013. EXPIRATION DATE: 2018-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.013 COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K072857) LOT. 130913. LOT 130913: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2013. EXPIRATION DATE: 2018-APR-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    UNCHANGED PAIN. ESPECIALLY DURING EXERTION, AFTER WALKING 200 M, PAIN IN THE LEFT HIP OCCURS. THE PAIN IS ORIENTED ANTEROLATERALLY. PAIN AT NIGHT OR AT REST IS LESS PREDOMINANT. REVISION SURGERY PERFORMED 8 YEARS AND 6 MONTHS AFTER THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132189 STEM: AMISTEM H HA COATED LAT STEM SIZE 4 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.144 131562 07630030804205

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention