BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 9X30MM IMPL STEM W/SCR

    MDR report key: 7895731 · Received September 20, 2018

    Report

    Report Number
    0001825034-2018-08999
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    August 24, 2018
    Report Date
    September 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI- (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-210043 EXPLOR 14X24 MM IMPLANT HEAD 386230. . THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING 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 · 0

    THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT WAS CONFIRMED BASED ON THE X-RAYS THAT WERE PROVIDED. X-RAY REVIEW SHOWS OVERALL FIT AND ALIGNMENT OF THE RADIAL HEAD ARTHROPLASTY IS APPROPRIATE. NORMAL BONE QUALITY. SCREW NOTED WITHIN THE POSTERIOR JOINT SPACE SUGGESTING HARDWARE DISASSEMBLY. THE SCREW AND MOD HEAD WERE RETURNED FOR EVALUATION. THE STEM DID NOT RETURN. THE THREADS ON THE SCREW ARE DAMAGED, ALTHOUGH IT IS HARD TO SEE UNLESS UNDER MAGNIFICATION WITH A LOUP. THE SCREW HEAD DIAMETER AND SCREW THREAD MAJOR OD WAS MEASURED AND FOUND TO BE CONFORMING TO SPECIFICATIONS. THE THRU HOLE OF THE MOD HEAD WAS MEASURED WITH PIN GAGE AND ALSO FOUND TO BE DIMENSIONALLY CONFORMING. A THREAD GAGE WAS NOT USED TO MEASURE THREAD FORM OF THE SCREW BECAUSE OF THE DAMAGE TO THE THREADS. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME TO REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-210043 EXPLOR 14X24 MM IMPLANT HEAD UNKNOWN; UNKNOWN EXPLOR STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09043.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RADIAL HEAD REPLACEMENT. SUBSEQUENTLY, THE SCREW DISASSOCIATED AND THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE HEAD AND SCREW APPROXIMATELY SIXTEEN (16) MONTHS POST-IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735768 EXPLOR 9X30MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. N/A 690880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R