BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 17194722 · Received June 23, 2023

    Report

    Report Number
    3005180920-2023-00460
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 26, 2023
    Report Date
    July 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATA CORRECTED: EVENT DESCRIPTION. IN THE INITIAL REPORT, IT WAS REPORTED THAT THE STEM WAS REVISED. STEM WAS NOT REVISED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FROM THE EVENT DESCRIPTION AND FROM THE COMPONENT RECEIVED WE CAN SEE THAT THE CERAMIC BALL HEAD REF. 01.29.209 Ø36 SIZE M, LOT 2012924, DO NOT SHOW ANY MAJOR DEFECTS, ONLY SMALL SCRATCHES ARE VISIBLE ON THE EXTERNAL SURFACE OF THE BALL HEAD, NO OTHER PARTICULAR SIGNS ARE VISIBLE INSIDE THE CONICAL CAVITY OF THE BALL HEAD. IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE, BUT IT IS POSSIBLE THAT THE SIGNS OVER THE EXTERNAL BALL HEAD SURFACE PROBABLY WERE CAUSED BY METAL DEBRIS SMEARED BETWEEN THE BALL HEAD AND LINER BUT THEIR ORIGIN ARE NOT KNOWN. EVEN THE INTERNAL SIGNS COULD BE CAUSED DURING THE COMPONENT REMOVAL PHASE. UNFORTUNATELY, THE STEM IS NOT AVAILABLE, IT COULD HAVE HELPED TO BETTER UNDERSTAND THE REASON OF THE EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION SURGERY ABOUT 1 YEAR POST-PRIMARY DUE TO SUSPECTED PSEUDOTUMOR. THE CAUSES POTENTIALLY RELATED TO THE ARTIFICIAL JOINT ARE NOT DETERMINED. ACCORDING TO THE R&D ANALYSIS, ONLY SMALL SCRATCHES ARE VISIBLE ON THE EXTERNAL SURFACE OF THE BALL HEAD, NO OTHER PARTICULAR SIGNS ARE VISIBLE INSIDE THE CONICAL CAVITY OF THE BALL HEAD, SO THERE IS NO REASON TO SUSPECT THAT A PROBLEM AT THE JUNCTION BETWEEN THE STEM AND HEAD CAUSED THE ADVERSE REACTION. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE INFORMATION AT HAND.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 JUNE 2023: LOT 2012924: 139 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: STEM: AMISTEM H 01.18.233 STEM COLLARED HA COATED STD STEM SIZE 3 (K121011) LOT 2013505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2021. EXPIRATION DATE: 2026-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY ABOUT 1 YEAR POST-PRIMARY FOR SUSPECTED PSEUDOTUMOR. THE MEDACTA HEAD WAS REVISED. THE MEDACTA STEM WAS NOT REVISED. CUP AND LINER ARE COMPETITOR DEVICES.

    Description of Event or Problem · 0

    REVISION SURGERY ABOUT 1 YEAR POST-PRIMARY FOR SUSPECTED PSEUDOTUMOR. THE MEDACTA STEM AND HEAD WERE REVISED. CUP AND LINER ARE COMPETITOR' DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988584 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2012924 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Required Intervention