BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C

    MDR report key: 9768961 · Received February 28, 2020

    Report

    Report Number
    3007963827-2020-00061
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 5, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024471023
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATELLA BAJA IS DEFINED BY THE INSALL-SALVATI RATIO (PATELLAR TENDON LENGTH-LENGTH OF THE POSTERIOR SURFACE OF THE TENDON FROM THE LOWER POLE OF THE PATELLA TO ITS INSERTION ON THE TIBIAL TUBERCLE) DIVIDED BY (PATELLAR LENGTH-GREATEST POLE-TOPOLE LENGTH). IN THIS PROVIDED IMAGE, THE RATIO MEASURES 0.817. PATELLA BAJA OCCURS WHEN THE RATIO MEASURES LESS THAN 0.8, INDICATING BORDERLINE PATELLA BAJA. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS, AS WELL AS BONE QUALITY, APPEAR NORMAL. ONE-PAGE CLINIC NOTE IS FOR INITIAL SURGICAL PLANNING AND SCHEDULING. NO OTHER INFORMATION WAS PROVIDED. PATELLA BAJA WAS CONFIRMED HOWEVER, PAIN AND STIFFNESS ISSUES CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6204-022-23 PERSONA THE PERSONALIZED KNEE SYSTEM: PAIN IS KNOWN ADVERSE EFFECT OF THE SYSTEM. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3007963827-2020-00060; 3007963827-2020-00062. CONCOMITANT MEDICAL PRODUCT: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT, ITEM# 42502005402, LOT# 63405040. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT, ITEM# 42522000410, LOT# 64093156. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND TWO MONTHS¿ POST IMPLANTATION DUE TO PAIN AND STIFFNESS. SURGEON STATED THE IMPLANT APPEARED WELL ALIGNED BUT OVERSIZED PATELLA BAJA WAS NOTED. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232255 TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63846697 00889024471023

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R