BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 31MM

    MDR report key: 11464660 · Received March 11, 2021

    Report

    Report Number
    0001825034-2021-00732
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    November 16, 2020
    Report Date
    September 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304554412
    PMA / PMN Number
    K083782
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B6; D2; G1; G3; G6; H1; H2; H6. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H6. ADDITIONAL MEDICAL RECORDS WERE PROVIDED. NOTES REPORTED STIFFNESS AND PAIN COMING FROM PATELLA AFTER A FALL. X-RAY WAS TAKEN AND DID NOT SHOW ABNORMALITIES. OFFICE VISIT NOTES STATES THAT PATIENT'S KNEE CONTINUED GIVING PAIN AND GIVING OUT AND WAS TREATED WITH STEROID INJECTIONS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED PER THE MEDICAL RECORDS WHICH FOUND A BROKEN PATELLA COMPONENT CAUSING PAIN. A FIBROMA WAS EXCISED. A LOT OF SCAR TISSUE WAS FOUND BENEATH THE PATELLA. THE PATELLA WAS FOUND LOOSE AND WHEN REMOVED ALL 3-PEGS WERE FOUND BROKEN OFF AND REMAINED IN THE PATELLA. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF REGENEREX PATELLA FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. THIS EVENT WAS FARTHER INVESTIGATED THROUGH THE CAPA PROCESS. 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 · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWO YEARS POST-OP, THE PATIENT FELL AND BEGAN TO HAVE STIFFNESS AND PAIN IN THE PATELLA REGION. THE PATIENT REPORTED THAT THE KNEE WAS GIVING OUT AND THE PATIENT CONTINUED WITH PAIN UNTIL THEY WERE SUBSEQUENTLY REVISED 5 YEARS POST-OP. DURING THE REVISION, A FIBROMA WAS EXCISED, EXTENSIVE SCAR TISSUE BENEATH THE PATELLA WAS ENCOUNTERED, THE PATELLA WAS LOOSE, AND THREE PEGS OF THE PATELLA WERE FOUND FRACTURED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT VNGD PS OPEN POR FMRL RT 67.5 ITEM# 184510 LOT# 494730; BMET REGENX PRI TIB TRAY 71MM ITEM# 141273 LOT# 360190; BIOMET FINNED PRI STEM 40MM ITEM# 141314 LOT# 943150; RGX 3 PEG SER A PATELLA 31MM ITEM# 141356 LOT# 870260; E1 VNGD PS+ TIB BRG 71/75X14 ITEM# EP-183744 LOT# 575950. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY FIVE YEARS¿ POST-IMPLANTATION DUE TO PAIN, IMPLANT FRACTURE, SCAR TISSUE, AND LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362308 RGX 3 PEG SER A PATELLA 31MM PROSHTESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 870260 00880304554412

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R SEE H10