BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PEG SERIES PATELLA

    MDR report key: 7152200 · Received December 28, 2017

    Report

    Report Number
    0001825034-2017-11360
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 072300, EXPIRATION DATE - JUL 31, 2019, MANUFACTURE DATE ¿ JUL 20, 2014. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 515130, EXPIRATION DATE - JUL 31, 2019, MANUFACTURE DATE ¿ JUL 31, 2014. CONCOMITANT MEDICAL PRODUCTS - SIG TKA GDE/MDL SET 03-05 CATALOG #: 42-422551 LOT #: 114383, VANGUARD CR POR FEM-RT 67.5 CATALOG #: 183050 LOT #: 459090, BIOMET FINNED PRI STEM 40 MM CATALOG #: 141314 LOT #: 920950, BMET REGENX PRI TIB TRAY 75 MM CATALOG #: 141274 LOT #: 186300, VNGD CR TIB BRG 14X71/75 CATALOG #: 183444 LOT #: 441450, SIG TKA GDE/MDL SET 03-05 CATALOG #: 42-422551 LOT #: 114168, BIOMET FINNED PRI STEM 40 MM CATALOG #: 141314 LOT #: 715300, VNGD CR TIB BRG 10X71/75 CATALOG #: 183440 LOT #: 919800, BMET REGENX PRI TIB TRAY 75 MM CATALOG #: 141274 LOT #: 630180, AND VANGUARD CR POR FMRL-LT 67.5 CATALOG #: 183070 LOT #: 322470. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE PATELLAR FRACTURE WAS CONFIRMED THROUGH VISUAL INSPECTION. THE RETURNED PATELLA WAS IDENTIFIED TO HAVE ALL THREE PEGS ON THE RETURNED PATELLA FRACTURED OFF. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A CORRECTIVE AND PREVENTATIVE ACTION INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE ROOT CAUSE OF REGENEREX PATELLAS FRACTURING WAS A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF THE REGENEREX PATELLA FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. HOWEVER, IT IS UNKNOWN WHETHER THE PATELLA PEGS IN THIS CASE FRACTURED DUE TO ISSUES RELATED TO THE CORRECTIVE AND PREVENTATIVE ACTION INVESTIGATION OR THE TRAUMATIC FALL THAT WAS REPORTED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 WAS REVISED THREE YEARS AFTER INITIAL KNEE PROCEDURE DUE TO FRACTURE AFTER A FALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY DUE TO PATIENT FALL. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO IMPLANT FRACTURE IN WHICH THE PEGS SHEARED OFF. THE IMPLANT FRACTURE IS INDICATED TO BE A RESULT OF THE FALL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932644 REGENEREX PEG SERIES PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R