BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM EXTENSION OFFSET LONG 14MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM)

    MDR report key: 14197539 · Received April 25, 2022

    Report

    Report Number
    0001822565-2022-01178
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    August 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). YEAR OF BIRTH: (B)(6). FOREIGN COUNTRY: (B)(6). 00-5996-058-02 LCCK TIBIA SIZE 8, 00-5994-051-14 ART SURFACE. 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: 0001822565-2022-0105, 0001822565 - 2022 - 01179.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MECHANICAL (G04) - STEM. A VISUAL INSPECTION OF THE RETURNED TIBIAL COMPONENT FOUND IT TO EXHIBIT SIGNS OF BEING IMPLANTED WITH WEAR AND SCRATCHES. THE STEM EXTENSION HAS FRACTURED OFF IN THE POST AND THE POST HAS ALSO FRACTURED. THE STEM EXTENSION ALSO EXHIBITS SIGNS OF BEING IMPLANTED WITH NICKS AND SCRATCHES AND HAS FRACTURED OFF IN THE POST OF THE TIBIAL PLATE, WHICH WAS FOUND TO EXHIBIT SIGNS OF BEING IMPLANTED WITH SCRATCHES, WEAR AND DISCOLORATION. SEM ANALYSIS SHOWS THE FRACTURED SURFACE ARTIFACTS SUGGEST AN OVERLOAD FAILURE, INITIATING ON THE INSIDE EDGE WHICH COINCIDES WITH THE FRACTURE EXIT OF THE STEM FRACTURE SURFACE. THE PRESENCE OF BEACH MARKS SUGGESTS A FATIGUE FRACTURE. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES LOOSENING WITH SHAFT FRACTURE, TIBIAL PAIN AND RADIOGRAPHIC EVIDENCE OF SHAFT FRACTURE, GRAYISH SYNOVITIS NOTED, AND TIBIAL LOOSENING NOTED. X-RAY REVIEW SHOWS FRACTURE OF THE TIBIAL IMPLANT OF THE RIGHT KNEE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. THE PATIENT WAS REVISED DUE TO INFECTION WITH CEMENT SPACER PLACEMENT. THE CEMENT SPACER WAS REMOVED AND AN LCCK TKA PLACED WITHOUT COMPLICATION. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN AND RADIOGRAPHIC EVIDENCE OF IMPLANT FRACTURE. DURING THE REVISION, SYNOVITIS WAS NOTED. THE LOOSE TIBIAL COMPONENTS WERE REPLACED WITHOUT COMPLICATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636082 STEM EXTENSION OFFSET LONG 14MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM) PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 60350386

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEEH10NARRATIVE.