BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE WITH HINGE POST

    MDR report key: 10000571 · Received April 27, 2020

    Report

    Report Number
    0001822565-2020-01483
    Event Type
    Injury
    Date Received
    April 27, 2020
    Date of Event
    April 9, 2020
    Report Date
    August 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024199248
    PMA / PMN Number
    K173057
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED INITIAL OP NOTES FOUND NO COMPLICATION. SUBSEQUENTLY, PATIENT REVISED POLY DURING THE IRRIGATION AND DEBRIDEMENT FOR ITIS AND DELAYED WOUND HEALING. APPROXIMATELY 2 MONTHS AFTER THE REVISION, PATIENT EXPERIENCING CRACKING AND INSTABILITY. X-RAY REVIEW ALSO FOUND HARDWARE DISASSEMBLY WITH DISLODGED LOCKING BOLT. EXTENSION POST FOUND IN THE MEDIAL SIDE OF THE JOINT. POLY WAS EXCHANGED WITH NO COMPLICATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT: INSTABILITY IS KNOWN ADVERSE EFFECT OF THE SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: REF 00-5880-002-00 LOT 64357066E19 RHK TIBIAL PLATE. REF 00-5988-020-15 LOT 63694678F17 NEXGEN STEM EXTENSION 15X145MM. REF 00-5988-020-11 LOT 63810516K17 NEXGEN STEM EXTENSION 11X145MM. REF 00-5880-013-01 LOT 64201922E19 RHK FEMUR C. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE LOCATION OF DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT ROTATING HINGE TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE TWO WEEKS LATER DUE TO WOUND COMPLICATIONS. WITHOUT A KNOWN TRAUMATIC EVENT, THE PATIENT EXPERIENCED CRACKING AND INSTABILITY IN THE JOINT AND PRESENTED TO THE ER. X-RAYS SHOWED PROSTHESIS LUXATION WITH A LOOSENED COUPLING MECHANISM. THE PATIENT UNDERWENT A SECOND REVISION DURING WHICH THE POLY WAS EXCHANGED WITHOUT COMPLICATION APPROXIMATELY TWO MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464709 ARTICULAR SURFACE WITH HINGE POST PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64495411 00889024199248

    Patients

    Seq Age Sex Outcome Treatment
    0 Hospitalization| R
    1 Hospitalization| H| R| R SEE H10 NARRATIVE