BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36

    MDR report key: 16813414 · Received April 26, 2023

    Report

    Report Number
    3005180920-2023-00309
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809347
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26-APR-2023. LOT 19C0066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVE: BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 (K131518) LOT 2113578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2027-01-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.242A SLEEVE SIZE L (K131518) LOT 1907393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2019. EXPIRATION DATE: 2024-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL (K131518) LOT 19C0075: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-11-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3641HC4 OFFSET 4MM PE HC LINER Ø36/D (K183582) LOT 2111831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A RIGHT PRIMARY HIP SURGERY ON (B)(6) 2022 AND A LEFT PRIMARY HIP SURGERY ON (B)(6)2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY IN BOTH HIPS AND THE SURGEON REVISED THE HEAD AND LINER ON BOTH THE RIGHT AND LEFT SIDES. PRESENTLY, ON (B)(6)2023, THE SURGEON DETERMINED THAT THE PATIENT WAS OVER-LENGTHENED IN BOTH HIPS. THE SURGEON REVISED THE HEAD, SLEEVE, AND LINER ON BOTH SIDES OF THE HIP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668732 BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 HIP MECTACER HEAD BIOLOX LZO MEDACTA INTERNATIONAL SA 01.29.232H 19C0066 07630030809347

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention