BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI II UNICONDYLAR FEMORAL 45 MM LM/RL

    MDR report key: 6513040 · Received April 21, 2017

    Report

    Report Number
    0001825034-2017-02710
    Event Type
    Injury
    Date Received
    April 21, 2017
    Report Date
    August 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PK971938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE: CMP(B)(4). MEDICAL PRODUCT - REPICCI II UNICONDYLAR KNEE TIBIAL COMPONENT, CATALOG #: 102140, LOT #: 198860 PALACOS BONE CEMENT 40 GRAM, CATALOG #: 424800, LOT #: 003341 CUSTOMER HAS NOT INDICATED IF 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 REPORT:0001825034-2017-02711

    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 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT DATE - COULD BE (B)(6) 2005 OR (B)(6) 2005; EXPLANT DATE - COULD BE (B)(6) 2005 OR (B)(6) 2005; THERAPY DATE - COULD BE (B)(6) 2005 OR (B)(6) 2005. THE INFORMATION CONTAINED WITHIN THIS REPORT DOES NOT ALTER PREVIOUS CONCLUSIONS. 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 FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FROM A PARTIAL KNEE TO A TOTAL KNEE 3 YEARS POST-IMPLANTATION DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292427 REPICCI II UNICONDYLAR FEMORAL 45 MM LM/RL PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS 743830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10