BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS SLAP HAMMER

    MDR report key: 2943789 · Received February 5, 2013

    Report

    Report Number
    1220246-2013-00008
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION REVEALED ONE DEVICE RETURNED WITH DAMAGED END (BALL BROKEN OFF DISTAL END OF DEVICE). REVISION INVOLVED REMOVAL OF A STEM 10+ YEARS AFTER INITIAL SURGERY AND IT IS UNKNOWN IF STEM WAS ORIGINALLY CEMENTED OR WHAT PREPARATIONS WERE TAKEN TO FREE THE STEM PRIOR TO ATTEMPTED REMOVAL. THE CAUSE OF THE EVENT IS UNDETERMINED. THE MOST LIKELY CAUSE OF THE EVENT IS THAT EXCESSIVE FORCE MAY HAVE FATIGUED THE BALL END OF THIS INSTRUMENT DURING THE ATTEMPTED REVISION PROCEDURE AS 100+ STRIKES WERE REPORTED. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE BROKE DURING REMOVAL. FIRST SURGERY WAS DONE IN 2002. REVISION DATE (B)(6) 2013. SURGERY WAS PERFORMED AND CULTURES WERE TAKEN, RESULTS UNKNOWN. GLENOID COMPONENT WAS REMOVED EASILY WITH AN OSTEOTOME. THE HUMERAL COMPONENT WAS MUCH MORE DIFFICULT. THE HEAD WAS REMOVED FROM THE MORRIS TAPER WITH EASE. THE LATERAL LOCKING SCREW WAS COVERED OVER WITH BONE. BONE WAS REMOVED TO VISUALIZE SCREW. HEX SCREW DRIVER LOOSENED SCREW AND THE TRUNNION WAS REMOVED. THE SLAP HAMMER WAS ATTACHED AND SCREW RETIGHTENED TO LOCK SLAP HAMMER IN PLACE. OVER 100 STRIKES OF THE SLAP HAMMER AND THE STEM DID NOT MOVE AT ALL. EVENTUALLY THE LITTLE BALL ON END OF SLAP HAMMER (PORTION THAT LOCKS INTO STEM) BROKE AND WAS LODGED INTO STEM. A HUMERAL OSTEOTOMY WAS NEEDED TO FREE STEM UP DISTALLY SO THAT STEM COULD BE REMOVED. THE OSTEOTOMY WAS THEN MADE THE SAME LENGTH AS THE STEM. EVENTUALLY THE STEM WAS REMOVED (4 HRS LATER). BLOOD LOSS WAS SIGNIFICANT. AN ANTIBIOTIC CEMENT SPACER WAS IMPLANTED SO THAT A REVISION COULD BE PERFORMED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48426 UNIVERS SLAP HAMMER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 1498031700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other