BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 22 SIZE S -2,5

    MDR report key: 11106972 · Received January 4, 2021

    Report

    Report Number
    3005180920-2021-00002
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    November 25, 2020
    Report Date
    February 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805486
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BATCH REVIEW: LOT 152708: 100 ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. 4 ITEMS WERE RE-STERILIZED BEFORE THE EXPIRATION DATE (LOT 152708A), RELEASED ON 01-JUL-2020, EXPIRATION DATE: 2025-06-15. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW: LINER: MPACT DM 01.26.2246MHC DOUBLE MOBILITY HC LINER 22.2/DMC (K092265) LOT 1910310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2025-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL INFO: PIECES RETURNED 12 FEB 2020. VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: VISUAL INSPECTION PERFORMED ON 18TH FEBRUARY 2021. FROM THE RECEIVED PIECES, THE HEAD AND LINER DID NOT SHOW ANY PARTICULAR SIGN OF DAMAGE RELATED TO THE EVENT. IN PARTICULAR, THE DIAMETER OF THE RETENTIVE PART OF THE LINER SEEMED NOT TO BE WORN OR OVALIZED, OR WITH OTHER DEFECTS THAT COULD HAVE CAUSED THE DISLOCATION OF THE BALL HEAD. ALSO FOR THE HEAD, NO PARTICULAR SIGNS ON THE SURFACE WERE NOTICED. THE PIECES WERE ANALYSED AND THE DIAMETER DIMENSIONS OF LINER AND HEAD RESULTED CONFORM. FROM THE PERFORMED ANALYSIS, THE ROOT CAUSE OF THE EVENT IS UNKNOWN, BUT A POSSIBLE REASON CAN BE RELATED TO A LOCK OF THE LINER TO AN ANATOMIC PORTION AND A SUBSEQUENT LEVER OF THE NECK STEM THAT CAUSED THE DISLOCATION OF THE BALL HEAD FROM THE LINER.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 DECEMBER 2020: LOT 152708A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2010. EXPIRATION DATE: 2015-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 17 DECEMBER 2020: LINER: MPACT DM 01.26.2246MHC DOUBLE MOBILITY HC LINER 22.2/DMC (K092265) LOT 1910310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JUN-2020. EXPIRATION DATE: 2025-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO DISLOCATION OF THE HEAD FROM THE LINER, 2 MONTHS AFTER PRIMARY SURGERY. HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9023 COCR BALL HEAD 12/14 22 SIZE S -2,5 HIP BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.124 152708A 07630030805486

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention