BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    MDR report key: 13711507 · Received March 9, 2022

    Report

    Report Number
    3005180920-2022-00157
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    February 7, 2022
    Report Date
    April 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805479
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2022. LOT 188819: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2019. EXPIRATION DATE: 2024-01-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY (B)(4) PROJECT MANAGER FROM THE RECEIVED PIECES, THE HEAD IS DISLOCATED FROM THE DM LINER, WHILE THE DM LINER SHOWS CLEAR SIGNS ON THE BASE RIM, PROBABLY OCCURRED DURING IMPINGEMENT WITH THE STEM OR DURING THE REVISION. QUALITY CONTROL MEASUREMENTS WERE PERFORMED, REVEALING THAT THE DIMENSIONS OF THE LINER ARE IN SPECIFICATION, SO WE CAN EXCLUDE A DEFECT OF THE PART. FROM THE RECEIVED INFORMATION, WE CAN NOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, EVEN IF A POSSIBLE CAUSE CAN BE RELATED TO AN HIGH LEVER ARM APPLIED TO THE HEAD, THAT BROUGHT TO THE EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 16 FEBRUARY 2022. LINER: MPACT 01.26.2246 MHC DOUBLE MOBILITY HC LINER Ø 46/22.2 (K092265) LOT 1901453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    ON 21-MARCH-2022 XRAYS ANALYSIS WAS PERFORMED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR HIP INTRAPROSTHETIC DISLOCATION 1 MONTH AFTER INDEX IMPLANTATION. A DISLOCATION OCCURED OF THE FEMORAL HEAD FROM THE DOUBLE MOBILITY LINER. DISLOCATION OF THE HEAD FROM THE LINER IS USUALLY CAUSED BY EXTREME POSITIONS WHEN THE MOVEMENT OF THE MOBILE INSERT IS IMPEDED BY SURROUNDING TISSUES: IN THIS CASE, THE CUP APPEARS TO BE OF SIGNIFICANT SIZE, MARKEDLY PROTRUDING FROM THE ACETABULUM: A SITUATION THAT WAS PROBABLY DICTATED BY INDIVIDUAL PATIENT CONDITIONS (NOT VISIBLE IN THE POSTOPERATIVE XRAY) BUT THAT MAY IMPLY LIMITATIONS TO THE RANGE OF MOTION. THE SIZE OF THE MODULAR HEAD, 22MM, OBVIOUSLY COMMANDED BY THE SMALL SIZE OF THE PATIENT, IS A FURTHER LIMITING FACTOR FOR THE FINAL STABILITY OF THE ARTICULATION.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 2 MONTHS FROM PRIMARY DUE TO INTRAPROSTATIC DISLOCATION OF THE METAL HEAD FROM THE DOUBLE MOBILITY LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2651636 BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.123 188819 07630030805479

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention