BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCED SIZE ONCOLOGY SALVAGE SYSTEM -OSS RS 7 CM MOD SEG FMRL

    MDR report key: 6848201 · Received September 7, 2017

    Report

    Report Number
    0001825034-2017-06936
    Event Type
    Injury
    Date Received
    September 7, 2017
    Report Date
    October 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN BIOMET BEARING. UNKNOWN BIOMET FEMORAL COMPONENT. UNKNOWN BIOMET TIBIAL TRAY. UNKNOWN BIOMET PATELLA. UNKNOWN BIOMET STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: OSS POLY BUMPER LOCK PIN CATALOG # 150510 LOT # 058800; OSS REINFORCED YOKE CATALOG # 150493 LOT # 029560; OSS RS POLY FEM BUSHINGS SET/2 CATALOG #161034 LOT# 2933230; OSS RS AXLE CATALOG # 161035 LOT # 299920; OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 919050; CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG #178711 LOT# 803270; OSS TIBIAL POLY BEARING 14MM CATALOG # 150411 LOT # 336080; OSS 9CM DIAPHYSEAL SEGMENT CATALOG # 150467 LOT# 839230. 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 TRENDS WERE IDENTIFIED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT KNEE ARTHROPLASTY ON UNKNOWN DATE, AND CURRENTLY HAS A COMPRESS SPINDLE IMPLANTED, AND IS SCHEDULED FOR A SECOND STAGE REVISION OF THE LEFT DISTAL FEMUR EXPANDABLE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629498 REDUCED SIZE ONCOLOGY SALVAGE SYSTEM -OSS RS 7 CM MOD SEG FMRL PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 351580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R