BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M

    MDR report key: 11581250 · Received March 29, 2021

    Report

    Report Number
    3005180920-2021-00254
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 29, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16.MARCH.2021: LOT 125387: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2013. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 16.MARCH.2021: CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 (K103352) LOT 122961: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2012. EXPIRATION DATE: 2017-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017. LINER: VERSAFITCUP DM 01.26.3644HCT FLAT PE HC LINER Ø 36 / E (K103352) LOT 130725: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2013. EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 7 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. IN 2018, THE PATIENT SAID SHE STARTED FEELING PAIN BUT DID NOT REPORT IT TO THE SURGEON. SHE SAID SHE MAY HAVE DISLOCATED AND SHE WAS ABLE TO REDUCE HER HIP HERSELF. PRESENTLY, THE PATIENT IS REPORTING PAIN AND SAYS THAT HER HIP FEELS LIKE IT LOCKS WHEN SHE IS STANDING AND FEEL IS AS IF IT IS GOING TO COME OUT WHEN SHE IS SITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480082 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 125387 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention