BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX SERIES A 3 PEG PATELLA 28MM

    MDR report key: 8749507 · Received July 1, 2019

    Report

    Report Number
    0001825034-2019-02722
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    May 14, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K083782
    Removal / Correction Number
    HHE 2017-15
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONSIDERED CONFIRMED AS AN IMAGE OF THE EXPLANTED DEVICE WAS PROVIDED. VISUAL INSPECTION OF THE PROVIDED PICTURES CONFIRMED THE FRACTURE OF PATELLA PEGS AND BLACKENED TISSUE. THE PROVIDED RADIOGRAPHS DEMONSTRATE NORMAL APPEARANCE OF RIGHT TKA. ASSESSMENT OF PRIMARY OPERATIVE NOTES IDENTIFIED NO COMPLICATIONS DURING THE INITIAL SURGERY. DURING THE REVISION SURGERY, BLACKENED SYNOVITIS FROM THE METALLOSIS WAS IDENTIFIED, BROKEN AND FAILED PATELLA WAS REMOVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: VGD PS OPEN POR FEM RT 62.5, ITEM# 184506, LOT# 110970; BMET REGENX PRI TIB TRAY 67MM, ITEM# 141272, LOT# 060410; BIOMET FINNED PRI STEM 40MM, ITEM# 141314, LOT# 919140; E1 VNGD PS TIB BRG 63/67X10 , ITEM# EP-183620, LOT# 475940. CUSTOMER HAS NOT INDICATED WHETHER THE 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. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION APPROXIMATELY 2 YEARS AND 6 1/2 MONTHS¿ POST IMPLANTATION DUE TO FRACTURE OF THE PATELLAR COMPONENT. INITIAL OPERATIVE NOTES STATE THAT THE PATELLAR COMPONENT WAS PRESS-FIT INTO PLACE AND THE KNEE WAS BROUGHT THROUGH FULL RANGE OF MOTION WITH GREAT STABILITY. NO COMPLICATIONS WERE NOTED. REVISION OPERATIVE NOTES STATE THAT THE SURGICAL SITE CONTAINED A LOT OF BLACKENED SYNOVITIS IN THE KNEE FROM METALLOSIS. WHEN THE PATELLAR COMPONENT WAS REMOVED, ALL THREE (3) OF THE PATELLAR PEGS WERE IDENTIFIED TO BE BROKEN. NO OTHER COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544734 REGENEREX SERIES A 3 PEG PATELLA 28MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 705930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R