BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S - 3.5

    MDR report key: 18585791 · Received January 26, 2024

    Report

    Report Number
    3005180920-2024-00002
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    January 2, 2024
    Report Date
    March 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809125
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 JANUARY 2024. LOT 2113855: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2021. EXPIRATION DATE: 2026-DEC-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 91 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 01 MARCH 2024. LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 (K092265) LOT 2000167: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 16-APR-2020. EXPIRATION DATE: 2025-MARCH-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 141 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER FROM THE RECEIVED PIECES, IT WAS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT; THE BALL HEAD WAS BROKEN IN TWO PARTS, BUT WITHOUT ANY PARTICULAR SIGN OF FAILURE RELATED TO THE PAIN, WHILE THE DM LINER DID NOT SHOW PARTICULAR SIGNS TOO, EXCEPT FOR SOME SCRATCHES MOST PROBABLY OCCURRED FOR THE REVISION AND THE FRICTION WITH THE PIECES OF THE BROKEN HEAD, ALSO BROKEN DURING REMOVAL.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 JANUARY 2024. LOT 2113855: (B)(4) MANUFACTURED AND RELEASED ON 20-DEC-2021. EXPIRATION DATE: 2026-DEC-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 91 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. DURING THE REVISION SURGERY, A BONE TAMP WAS USED TO REMOVE THE HEAD AND THE DM LINER FROM THE TRUNION. AFTER HITTING ONCE WITH MALLET, THE CERAMIC HEAD BROKE INTO MULTIPLE PIECES WITHIN THE DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973277 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S - 3.5 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2113855 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention