BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M

    MDR report key: 18272889 · Received December 6, 2023

    Report

    Report Number
    3005180920-2023-00935
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 LOT 2107507: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2021. EXPIRATION DATE: 2026-09-07. 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 AFFAIRS DEPARTMENT LATE INFECTION IN CEMENTED THA,1 YEAR AND 5 MONTHS AFTER PREVIOUS REVISION. THIS IS THE THIRD REVISION DUE TO INFECTION. FROM THE RADIOGRAPHIC IMAGE IT IS VISIBLE THE SUBPOPTIMAL POSITION OF THE STEM WHICH IT MAY BE DUE TO THE LOOSENING OF THE STEM. ACCORDING TO REPORT, THE LOOSENING HAPPENED DUE TO THE INFECTION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL INVOLVED IMPLANTS BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON MECTAPLUG 01.33.101 MECTAPLUG PE SIZE 1 LOT. 2115071 LOT 2115071: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2021. EXPIRATION DATE: 2026-12-09. 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. THIS PRODUCT IS NOT MARKETED IN US. BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON SCREWS: MPACT 01.32.6535 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 (K103721) LOT. 2101235 LOT 2101235: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2021. EXPIRATION DATE: 2026-03-02. 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 BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT. 2109249 LOT 2109249: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2021. EXPIRATION DATE: 2026-09-09. 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 BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON LINER: MPACT 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT. 2001310 LOT 2001310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2020. EXPIRATION DATE: 2025-04-23. 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. BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON CUP: MPACT 01.32.162DH ACETABULAR SHELL Ø62 TWO-HOLES (K132879) LOT. 179346 LOT 179346: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2018. EXPIRATION DATE: 2023-05-02. 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 BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON SHELL SCREW PLUG: MPACT 01.31.55TP SHELL SCREW PLUG (K103721) LOT. 2203098 LOT 2203098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2022. EXPIRATION DATE: 2027-03-29. 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 BATCH REVIEW PERFORMED ON 10 NOVEMBER 2023 ON STEM: QUADRA-C 01.12.044 CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14 (K083558) LOT. 2000273 LOT 2000273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 20256-05-10. 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.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION THAT CAUSED LOOSENING OF THE IMPLANTS. THE SURGEON EXPLANTED ALL INSITU IMPLANTS AND WILL REPLACE THEM WITH CEMENTED IMPLANTS ONCE THE INFECTION CLEARS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160387 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2107507 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention