BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCED SIZE OSS OSSADDITIONAL COMPONENTS- RS 8.5CM SEG FMRL RIGHT

    MDR report key: 6752949 · Received July 29, 2017

    Report

    Report Number
    0001825034-2017-05303
    Event Type
    Injury
    Date Received
    July 29, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 29, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK051479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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)(6). (B)(4). CONCOMITANT PRODUCTS ¿ OSS RS 18MM TIBIAL BEARING CATALOG 161097 LOT 913460; OSS TIBIAL YOKE CATALOG 150493 LOT 582320; OSS POLY TIBIAL BUSHING CATALOG 150476 LOT 889990; UNKNOWN OSS TIBIAL BASEPLATE; OSS POLY LOCK PIN CATALOG 150478 LOT 710100; OSS 21CM DIAPHYSEAL SEGMENT CATALOG 150473 LOT 890180; OSS RS POLY FEMORAL BUSHINGS CATALOG 161034 LOT 746770; OSS RS AXLE CATALOG 161035 LOT 274510. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL 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 REPORTS: 1825034-2017-03108, 1825034-2017-05298, 1825034-2017-05258, 1825034-2017-05259, 1825034-2017-05299, 1825034-2017-05300, 1825034-2017-05301, 1825034-2017-05302, 1825034-2017-05303.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO QUADRICEPS DEFICIENCY. THE PATIENT WAS ALSO REPORTED AS EXPERIENCING DISLOCATION AND DISASSOCIATION. 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
    533231 REDUCED SIZE OSS OSSADDITIONAL COMPONENTS- RS 8.5CM SEG FMRL RIGHT PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 965270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R