BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 5

    MDR report key: 16061011 · Received December 28, 2022

    Report

    Report Number
    3005180920-2022-00986
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    December 13, 2022
    Report Date
    December 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-DEC-2022: LOT 145415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115). LOT 152601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2015. EXPIRATION DATE: 2020-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT 153654: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A HIP REVISION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS PROBABLY THAT THE PATIENT CAME REPORTING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923392 STEM: AMISTEM H HA COATED STD STEM SIZE 5 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.135 145415 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention