BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 34MM

    MDR report key: 6681576 · Received June 30, 2017

    Report

    Report Number
    0001825034-2017-04497
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    April 30, 2015
    Report Date
    October 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VNGD PS+ TIB BRG 24X71/75MM, CAT#: 183754 LOT#: 486500. BIOMET TIBIAL LOCKING BAR, CAT#: 141205 LOT#: 984380. TI PPS VG PS CLSD BOX 62.5 RT, CAT#: CP115732 LOT#: 837170. BIOMET FINNED PRI STEM 80X15MM, CAT#: 141320 LOT#: 884540. BMET REGENX PRI TIB TRAY 71MM, CAT#: 141273 LOT#: 770260. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04492. 0001825034-2017-04493. 0001825034-2017-04494. 0001825034-2017-04495. 0001825034-2017-04496. 0001825034-2017-04497.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT IS CONFIRMED THROUGH RECEIPT OF PATIENT MEDICAL RECORDS. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD  (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. REVIEW OF THE X-RAYS (B)(6) 2015) BY THE SURGEON PROVIDED IN OP-NOTES IDENTIFIED NO EVIDENCE OF LOOSENING, SUBSIDENCE, LINEAR WEAR OR OSTEOLYSIS, AND THE COMPONENTS WERE FOUND TO BE WELL FIXED. IT WAS NOTED BY THE SURGEON THAT THE PATIENT IS PROGRESSING SLOWLY AND HAS SIGNIFICANT STIFFNESS IN THE KNEE. AFTER THE REVISION PROCEDURE (ON (B)(6) 2015), THE PATIENTS ROM WAS NOTED TO BE 0-125 DEGREES. DURING MANIPULATION, THE PATIENT WAS FOUND TO BE VERY STIFF AND HAVE ROM OF 3-80 DEGREES AND AFTER THE PROCEDURE, IT WAS NOTED TO BE 0-135. THE SURGEON NOTED THAT THE PATIENT IS UNDERTREATING HER PAIN AND NOT FOCUSING ON OBTAINING RANGE OF MOTION AS AGGRESSIVELY AS HE WOULD RECOMMEND. IT WAS REPORTED THAT THE PATIENT DID NOT FOLLOW THE POST-OP PROTOCOL PRESCRIBED BY THE SURGEON AND THAT CONTRIBUTED TO THE LIMITED RANGE OF MOTION AND STIFFNESS. A DEFINITIVE ROOT CAUSE FOR RECURRING PAIN COULD NOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER THE INVESTIGATION OF THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD KNEE MANIPULATION, DUE TO LIMITED RANGE OF MOTION AND PAIN, PERFORMED WHILE UNDER ANESTHESIA. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461530 RGX 3 PEG SER A PATELLA 34MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 983930

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R SEE H10 COMMENTS