BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR INSERTER THREADED SHAFT

    MDR report key: 5070240 · Received September 11, 2015

    Report

    Report Number
    0001825034-2015-03949
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 19, 2015
    Report Date
    November 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LKD
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. BASED ON DEVICE HISTORY RECORDS, THE PRODUCT WAS MADE TO PRINT AND CORRECT MATERIALS. HE THREADED INSERTER SHAFT CANNOT BE INSERTED INTO THE THROUGH HOLE OF THE HANDLE BODY DUE TO THE DAMAGE. INSTRUMENT LIKELY FAILED DUE TO EXCESSIVE IMPACTS TO THE STRIKE PLATE, WHICH DEFORMED MATERIAL AROUND THROUGH HOLE.

    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03948 / 03949).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE CUP INSERTER BECAME MARRED UPON IMPACTION AND THE INNER LOCK BOLT BECAME CAPTURED INSIDE THE HANDLE. THE ENTRY HOLE WAS ALSO DISFIGURED AND THE INNER BOLT COULD NOT PASS FREELY. THE DISTAL THREAD ALSO BECAME DEFORMED DUE TO IMPACTION. THE INNER POLY WAS SEATED BY IMPACTION. THE INSERTER WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602926 G7 STR INSERTER THREADED SHAFT PROSTHESIS, HIP LKD BIOMET ORTHOPEDICS N/A 373941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention