BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS

    MDR report key: 6415571 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01722
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    September 20, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK051479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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. MEDICAL PRODUCTS - OSS RS NON-MOD PLATE LONG 55 CATALOG #: 161021 LOT #: 037530, OSS REINFORCED YOKE CATALOG #: 150493 LOT #: 879890, OSS RS AXLE CATALOG #: 161035 LOT #: 623990, OSS POR PROX TIB STEM 10.5X150 CATALOG #: 150448 LOT #: 298560, INTRAMEDULLARY PLUG LGE CATALOG #: 130613 LOT #: 851560, INTRAMEDULLARY PLUG LGE CATALOG #: 130613 LOT #: 103020, OSS POLY LOCK PIN CATALOG #: 150478 LOT #: 010010, OSS POLY TIBIAL BUSHING CATALOG #: 150476 LOT #: 508250, OSS RS POLY FEM BUSHINGS SET/2 CATALOG #: 161034 LOT #: 186790, AND OSS RS 12MM LS TIBIAL BEARING CATALOG #: 161094 LOT #: 554350. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-01723, 0001825034-2017-03186, AND 0001825034-2017-03187. H3 OTHER TEXT : REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN BIOMET TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-01723. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL IMPLANTED. 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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT IS SCHEDULED FOR A REVISION OF THE FEMORAL AND TIBIAL COMPONENTS. 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
    194923 RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS 518680

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention