BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 14652253 · Received June 10, 2022

    Report

    Report Number
    3005180920-2022-00444
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-MAY-2022. LOT 2111789: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-OCT-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 24-MAY-2022: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2107470: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2021. EXPIRATION DATE: 2026-SEP-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER 28/DMG (K092265) LOT 2114155: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-OCT-27. 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: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2113557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2021. EXPIRATION DATE: 2026-NOV-24. 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

    ON (B)(6) 2022, PATIENT HAD A PRIMARY LEFT HIP SURGERY AND ON (B)(6) 2022 HE HAD A PRIMARY RIGHT HIP SURGERY. ON (B)(6) 2022 THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED A BILATERAL REVISION SURGERY AND REVISED HEADS AND LINERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365415 LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 2111789 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention