BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLY WIRE/PIGTAIL 16G COCR

    MDR report key: 6283313 · Received January 27, 2017

    Report

    Report Number
    0001825034-2017-00301
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    August 22, 2016
    Report Date
    May 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK993510
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CONCOMITANT MEDICAL PRODUCTS - INTEGRAL LATERALIZED POROUS FEMORAL CATALOG #: 11-162609 LOT #: 458620, MLRY TROCH CLAW COCR LARGE CATALOG #: 11-105021 LOT #: 216690, COCR MOD HEAD CATALOG #: 163663 LOT #: 325190, ALLY COCR CRIMP SLEEVE CATALOG #: 350844 LOT #: 324140. THIS IS 2 OF 2 REPORTS BEING FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00299 / 00301).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO ADVERSE EVENT, ONLY PRODUCT PROBLEM. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE REMAINS UNDETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY DURING WHICH CIRCLAGE WIRES WERE IMPLANTED. THE PATIENT WAS REVISED APPROXIMATELY 14 YEARS POST-IMPLANTATION, AND THE WIRES WERE FOUND TO BE FRACTURED. NO ISSUE WITH THE WIRES IS ALLEGED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY WITH A COMPETITOR PRODUCT DURING WHICH CIRCLAGE WIRES WERE IMPLANTED. THE PATIENT WAS REVISED APPROXIMATELY 14 YEARS POST-IMPLANTATION DUE TO COMPETITOR PRODUCT WEAR, AND THE WIRES WERE FOUND TO BE FRACTURED. NO ISSUE WITH THE WIRES IS ALLEGED TO HAVE CAUSED THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66321 ALLY WIRE/PIGTAIL 16G COCR PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A 892730

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R