BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM

    MDR report key: 6897165 · Received September 27, 2017

    Report

    Report Number
    0001825034-2017-07394
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    February 21, 2017
    Report Date
    December 15, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. STERILIZATION CERTIFICATE SHOWS THIS DEVICE WAS STERILIZED PER SPECIFICATIONS. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). CONCOMITANT MEDICAL PRODUCTS - CP113459 OSS RS AVL 9 CM PROX TIB MOD 053510, 150466 OSS 7 CM DIAHPYSEAL SEGMENT 489680, 150387 OSS POROUS IM STEM 16.5 X 90 502150, 161073 OSS AVL TIBIAL LOCK RING 832930, 161071 OSS AVL POLY TIB BUSHING SET 283670, 161034 OSS RS POLY FEM BUSHINGS SET/2 394290, 161035 OSS RS AXLE 373600, 161068 OSS AVL TIB BEARING 12 MM 185290, 161075 OSS AVL YOKE 12 MM 472590. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.   MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07395, 0001825034-2017-07396, 0001825034-2017-07397, 0001825034-2017-07398 AND 0001825034-2017-07399.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO INFECTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677273 OSS POROUS IM STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 951720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R