BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L

    MDR report key: 20320101 · Received September 27, 2024

    Report

    Report Number
    3005180920-2024-00763
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2024: LOT 2211901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIR DIRECTOR: A DISLOCATION WAS REPORTED A FEW MONTHS AFTER THE PRIMARY IMPLANTATION OF A TOTAL HIP ARTHROPLASTY (THA). THE AVAILABLE IMAGES CLEARLY CONFIRM THE DISLOCATION AND ALSO REVEAL A SLIGHTLY UNDERSIZED STEM, WITH POSSIBLE MOBILIZATION VISIBLE ON THE DISLOCATION X-RAY. ADDITIONALLY, A BONY DEFECT IS EVIDENT ON THE SUPERIOR ASPECT OF THE ACETABULUM, ALONG WITH A DISPLACED BONE FRAGMENT. HIP DISLOCATION IS A WELL-KNOWN COMPLICATION FOLLOWING THA AND CAN RESULT FROM COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING. IN THIS CASE, THE PRESENCE OF THE ACETABULAR DEFECT MAY HAVE COMPROMISED THE COMPETENCE OF THE SOFT TISSUE ENVELOPE, CONTRIBUTING TO THE DISLOCATION. IT IS UNLIKELY THAT THE DISLOCATION CAN BE ATTRIBUTED TO THE STANDARD DEVICES USED. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2024: LINER: MECTACER 01.29.409 CERAMIC LINER Ø 32 / D LOT 2006662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2020. EXPIRATION DATE: 2025-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ITEM NOT REGISTERED IN US.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO HIP LUXATION AT ABOUT 5 MONTHS POST PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739453 MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2211901 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention