BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTICULAR SURFACE

    MDR report key: 11992757 · Received June 14, 2021

    Report

    Report Number
    0001822565-2021-01628
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 26, 2021
    Report Date
    November 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE PATIENT WAS PRESENTED WITH SUBLUXATION. DURING THE PATIENT REVIEW WITH X-RAY, THE HINGE POST AXIS WAS FRACTURED. DURING THE SURGERY, THE SURGEON CONFIRMS FRACTURE OF HINGE POST WITH DISLOCATION OF BEARING AND DEFORMED POLY BOX. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF USE. THE HINGE POST WAS FRACTURED. THE DAMAGE IN THE POLY BOX IS RELATED TO BEING IN-VIVO AFTER THE HINGE POST-FRACTURE AND THE ARTICULAR SURFACE WAS NOT RETURNED. THE DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED FRACTURE IS MIGHT BE RELATED TO FATIGUE. THE HINGE POST-FRACTURE SURFACE SHOWED A SUSPECTED RATCHET MARK, WHICH IS INDICATIVE OF FATIGUE CRACK INITIATION NEAR THE OUTER DIAMETER OF THE HINGE POST. THE MATERIAL ANALYSIS WAS FOUND TO CONFORMING TO PRINT SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. D10: DISTAL FEMORAL COMPONENT CATALOG#: 00585001301. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT SEGMENTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN AND SUBLUXATION DURING NORMAL WALKING. THE PATIENT WAS REDUCED AND TRANSFERRED TO SURGERY WHERE REVISION OF THE KNEE REVEALED A BENT AND FRACTURED HINGE POST WITH DAMAGE TO THE SURROUNDING POLY. THE DISTAL FEMORAL COMPONENT, HINGE, AND POLY WERE EXCHANGED WITHOUT COMPLICATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY: (B)(6). IMPLANT DATE: (B)(6) 2020. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN DISTAL FEMORAL COMPONENT. UNKNOWN ZSS-HINGE POST. UNKNOWN KNEE POLYETHYLENE INSERT. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-01627, 0001822565-2021-01629, 0001822565-2021-01630.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY, SUBSEQUENTLY; THE PATIENT WAS REVISED APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO PAIN, LIMITED MOBILITY, SUSPECTED AXIAL FRACTURE, DISLOCATED ARTICULAR SURFACE, AND DEFORMED POLYETHYLENE INSERT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890650 UNKNOWN ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R SEE H10 NARRATIVE.