BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS HUMERAL EXPANDABLE

    MDR report key: 6590286 · Received May 25, 2017

    Report

    Report Number
    0001825034-2017-03417
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    April 27, 2017
    Report Date
    October 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT ¿ STEM EXTENSION STRAIGHT 10MM DIA X 100MM LENGTH(COMBINED LENGTH 145MM), CAT#: 00598801010 LOT#: 63245722. COMP RVS 2.7MM DIA DRL, CAT#: 405889 LOT 423580 (2QTY). PERIA 3.5X16 BONE SCW LCK-CANN, CAT#: 27716 LOT#: NI (2QTY). PERIA 3.5X20 BONE SCW LCK-CANN, CAT#: 27720 LOT#: NI (2QTY). PERIA 3.5X32 BONE SCW LCK-CANN, CAT#: 27732 LOT#: NI (2QTY). CALIBRATED 2.7MMX250MM, CAT#: 27570 LOT#: NI. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [HOSPITAL KEPT] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IMPLANT DATE: N/A, DEVICE WAS NOT IMPLANTED. ROOT CAUSE REMAINS UNCHANGED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY DISCUSSION WITH THE PMI DESIGN ENGINEERS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO MISUNDERSTANDING BETWEEN PMI (CUSTOM DEPARTMENT) AND THE SURGEON. IT WAS ACKNOWLEDGED THAT THE SURGEON SIGNED OFF ON THE FINAL DESIGN NOTICE AND THEREFORE, HAD APPROVED THE DESIGN. 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 WAS REPORTED THAT DURING A RIGHT CUSTOM SHOULDER ARTHROPLASTY, THE PATIENT-SPECIFIC IMPLANT WAS TOO LONG TO FIT THE PATIENT'S ANATOMY. A DIFFERENT COMPONENT IN CONJUNCTION WITH A FEW OF THE CUSTOM COMPONENTS WERE USED INSTEAD TO COMPLETE THE PROCEDURE AFTER A THIRTY MINUTE DELAY. THE PATIENT HAS BEEN INDICATED FOR A FUTURE REVISION TO IMPLANT NEW PARTS THAT ARE ADEQUATE FOR THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372878 COMPREHENSIVE SRS HUMERAL EXPANDABLE PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 888810

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention