BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5

    MDR report key: 18371294 · Received December 21, 2023

    Report

    Report Number
    3005180920-2023-01017
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    October 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805141
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 NOVEMBER 2023 LOT 1901505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2019. EXPIRATION DATE: 2024-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT 2302832: 77 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT DM 01.32.4452CF DM CONVERTER TIN COATED G/DMF (K211891) LOT 2249471: 20 ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PREVIOUS MDR SENT: 2022-00637 2022-00696 2023-00238 2023-00737 2023-00918

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON 18 DEC 2019. SUBSEQUENTLY, THE HEAD DISLOCATED FROM THE LINER. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. SUBSEQUENTLY, THE PATIENT CAME IN SUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6) 2023, THE SURGEON REVISED THE HEAD AND LINER AND IMPLANTED A DM CONVERTER. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168228 BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 HIP BALL HEAD JDI MEDACTA INTERNATIONAL SA 1901505 07630030805141

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention