BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX SERIES-A PATELLA

    MDR report key: 7345524 · Received March 16, 2018

    Report

    Report Number
    0001825034-2018-01993
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    June 19, 2017
    Report Date
    January 10, 2020
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE METAL PEGS HAVE SHEARED OFF AND THAT THE ARTICULATING SURFACE HAS NICKS AND GOUGES FROM REPEATED USE. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS ¿ MEDICAL PRODUCT: VANGUARD POSTERIOR STABILIZED FEMORAL COMPONENT, CATALOG #: 184502, LOT #: 182220. BIOMET REGENEREX TIBIAL TRAY, CATALOG #: 141272, LOT #: 865280. BIOMET FINNED STEM, CATALOG #: 141314, LOT #: 743330. VANGUARD POSTERIOR STABILIZED BEARING, CATALOG #: 183620, LOT #: 095740. 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

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.REPORTED EVENT HAS BEEN CONFIRMED BY REVIEW OF PHOTOS AND OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH THE FOLLOWING DEVIATIONS: 1 PIECE OF SCRAP AT OP 260 AND ONE SCRAP AT OP 265 FOR CARBON TESTING; 15 PIECES REWORKED DUE TO INCORRECT WATER BEING USED DURING CLEARNING; ONE UNIT REWORKED DUE TO FLASH EXCEEDING .060"; FIVE PIECES REWORKED DUE TO CRUSHED RETAINERS; THREE PIECES SCRAPPED DUE TO EXCESS POLY ON THE METAL. THE REPROTED EVENT HAS BEEN PREVIOUSLY IDENTIFIED AND WAS INVESTIGATED AS PART OF CA-03298. PER CA-03298, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT WAS 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.

    Description of Event or Problem · 0

    OPERATIVE REPORTS RECEIVED INDICATES THAT DURING THE REVISION PROCEDURE THE SURGEON REMOVED METALLOSIS WITHIN THE SOFT TISSUES.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE 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 UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS MECHANICAL BREAKAGE OF THE METAL BACKED PATELLAR IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190137 REGENEREX SERIES-A PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 705930

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R