BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SEGMENTAL ELLIPTICAL FEMORAL 7 CM RIGHT POROUS COATED

    MDR report key: 6689967 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04540
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 6, 2017
    Report Date
    July 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04970. 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. 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

    (B)(4) MEDICAL PRODUCT-OSS POROUS IM STEM 18.5 X 225 CATALOG# 150405 LOT# 724800, OSS TIBIAL POLY BEARING 12 MM CATALOG# 150410 LOT# 720790, OSS RESURF FEM SLEEVE AUG RT CATALOG# 150453 LOT# 212100, OSS RESURF FEM SLEEVE AUG LT CATALOG# 150454 LOT# 837710, OSS POLY FEMORAL BUSHINGS 2 PK CATALOG# 150477 LOT# 236380, OSS POLY LOCK PIN CATALOG# 150478 LOT# 482740, OSS AXLE CATALOG# 150480 LOT# 909840, OSS REINFORCED YOKE CATALOG# 150493 LOT# 502280. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [LOCATION UNKNOWN AT THIS TIME] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 THE PATIENT HAD A REVISION SURGERY TO ADDRESS ASEPTIC COMPONENT FEMORAL LOOSENING. ALL ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472251 OSS SEGMENTAL ELLIPTICAL FEMORAL 7 CM RIGHT POROUS COATED PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 845500

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R