BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA)

    MDR report key: 17779920 · Received September 20, 2023

    Report

    Report Number
    3005180920-2023-00728
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 20, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K073337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 AUGUST 2023: LOT 092211: 50 ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2009. EXPIRATION DATE: 2014-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 30 AUGUST 2023: LINER: VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY LINER Ø 50/28 (K083116) LOT 092005: 59 ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2009. EXPIRATION DATE: 2014-JUL-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL CC Ø 50 (K083116) LOT 090908: 40 ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2009. EXPIRATION DATE: 2014-APR-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: QUADRA-H 01.12.23SN CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK (K082792) LOT 090823: 45 ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2009. EXPIRATION DATE: 2014-APR-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 13 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO DISCOMFORT. X-RAYS INDICATED SOME RADIOLUCENCY AROUND THE STEM AND CUP. WHEN THE SURGEON WENT IN TO REVISE, IT WAS NOTICED THAT THE CUP AND STEM WERE WELL FIXATED, BUT THE LINER AND HEAD HAD SOME WEAR AND WAS STIFF. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83414 MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA) HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 092211

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention