BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM - OSS REINFORCED YOKE

    MDR report key: 6557520 · Received May 10, 2017

    Report

    Report Number
    0001825034-2017-03186
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    September 20, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS RS 5 CM RESURF FMRL-LT, CATALOG #: 161008, LOT #: 518680; OSS RS NON-MOD PLATE LONG 55, CATALOG #: 161021, LOT #: 037530; 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-01722, 0001825034-2017-01723, AND 0001825034-2017-03187. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    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
    338278 ORTHOPEDIC SALVAGE SYSTEM - OSS REINFORCED YOKE PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS 879890

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention