BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0

    MDR report key: 15310353 · Received August 29, 2022

    Report

    Report Number
    3005180920-2022-00651
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    July 30, 2022
    Report Date
    August 29, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 AUGUST 2022: LOT 2115839: 199 ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2022. EXPIRATION DATE: 2027-02-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 174 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 26 AUGUST 2022: AMISTEM-P COLLARED STEM SIZE 1 (K173794) LOT 2117759: 78 ITEMS MANUFACTURED AND RELEASED ON 20-APR-2022. EXPIRATION DATE: 2027-04-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. IMPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES (K132879) LOT 2115080: 104 ITEMS MANUFACTURED AND RELEASED ON 09-02-2022. EXPIRATION DATE: 2027-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 68 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. IMPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT 2100152: 165 ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2021. EXPIRATION DATE: 2026-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 138 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. IMPACT 01.43.0020 CANCELLOUS BONE SCREW Ø 6,5 L 20 (K200391) LOT 2208669: 317 ITEMS MANUFACTURED AND RELEASED ON 08-JUNE-2022. EXPIRATION DATE: 2027-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 125 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS AND RE-IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100792 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.205 2115839 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention