BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX SERIES A PATELLA 3 PEG DCM ARCOM POROUS TITANIUM

    MDR report key: 7781333 · Received August 14, 2018

    Report

    Report Number
    0001825034-2018-04776
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    May 16, 2018
    Report Date
    January 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BY THE REVISION OPERATIVE REPORT WHICH NOTED AREAS OF BLACK METALLOSIS WITHIN THE SYNOVIUM ALONG BOTH GUTTERS, RECESSES AND THE SOFT TISSUES BEHIND THE PATELLAR TENDON. THE FRACTURED PATELLA HAD BEEN IDENTIFIED IN THE LATERAL GUTTER AND REMOVED. THE PEGS WERE STILL PRESENT AND INGROWN INTO THE PATELLA. THERE WAS BONE LOSS SEEN. THE DEVICE WAS NOT RETURNED BACK FOR EVALUATION BUT VISUAL INSPECTION OF THE PHOTOGRAPHS FOR THE EXPLANTED PATELLA SHOWS ALL THREE PATELLA PEGS ARE FRACTURED OFF THE DEVICE AS WELL AS BONE GROWTH ON THE DEVICE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE 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; CORRECTIVE ACTIONS WERE INITIATED. 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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND PHOTOGRAPHS. THE DEVICE WAS NOT RETURNED BACK FOR EVALUATION, HOWEVER, VISUAL INSPECTION OF PHOTOGRAPHS FOR THE EXPLANTED PATELLA IMPLANT SHOWS ALL THREE PATELLA PEGS ARE FRACTURED OFF THE DEVICE. THERE IS BONE GROWTH SEEN ON THE DEVICE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE 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. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    PATIENT'S LEGAL COUNSEL HAS ADDITIONALLY REPORTED PATIENT EXPERIENCED LOSS OF MOBILITY AND RANGE OF MOTION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR POR FMRL-LT 70, CATALOG #: 183072, LOT #: 902520; BMET REGENX PRI TIB TRAY 75MM, CATALOG #: 141274, LOT #: 849430; E1 VNGD AS TIB BRG 14X75, CATALOG #: EP-189084, LOT #: 704090; BIOMET FINNED PRI STEM 40MM, CATALOG #: 141314, LOT #: 943150. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT'S LEGAL COUNSEL REPORTED THE PATIENT WAS EXPERIENCING PAIN APPROXIMATELY TWO AND HALF YEARS POST-IMPLANTATION. PATIENT'S OPERATIVE REPORTS INDICATE THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATELLAR MECHANICAL FAILURE AND CHRONIC EFFUSION SECONDARY TO FAILED IMPLANTED. IT WAS FURTHER NOTED THAT THE THREE PATELLA PEGS HAD SHEARED OFF THE IMPLANT RESULTING IN EXCESSIVE METALLOSIS, DEBRIS AND SYNOVIAL FLUID LOCATED ALONG BOTH GUTTERS, RECESSES, AND SOFT TISSUES BEHIND THE PATELLAR TENDON. BLACK MATERIAL WAS ALSO NOTED TO BE LOCATED WITHIN THE POLYETHYLENE BEARING. THEREFORE, THE PATELLA AND POLYETHYLENE BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622828 REGENEREX SERIES A PATELLA 3 PEG DCM ARCOM POROUS TITANIUM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 044810

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R SEE H10 NARRATIVE