BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16194486 · Received January 18, 2023

    Report

    Report Number
    3005180920-2022-00993
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 18, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 22 DECEMBER 2022 LOT 2207392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2022. EXPIRATION DATE: 2027-06-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 22 DECEMBER 2022 ON LINER: MPACT 01.32.3644HCAT HOODED PE HC LINER Ø36/E (K132879) LOT. 2201678. LOT 2201678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MARCH-2022. EXPIRATION DATE: 2027-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 22 DECEMBER 2022 ON STEM: M-VIZION 01.22.105 DISTAL STEM Ø16MM L 140MM STRAIGHT (K170690) LOT. 2010764. LOT 2010764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUNE-2021. EXPIRATION DATE: 2026-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 22 DECEMBER 2022 ON STEM: M-VIZION 01.22.404 PROXIMAL BODY Ø20MM L 70MM STD WITH HOLES (K201471) LOT. 2010777. LOT 2010777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 22 DECEMBER 2022 ON CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT. 2115587. LOT 2115587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2022. EXPIRATION DATE: 2027-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THAT WAS CAUSED FROM FALLING. THE SURGEON CABLED THE FRACTURE, AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PREFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INFECTION CASE OF THE (B)(6) 2022 WAS REPORTED IN THE MDR 2022-00976, IN WHICH IT IS NOT MENTIONED THE PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3773 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2207392 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention