BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM ELLIP DIAPHYSEAL SEG

    MDR report key: 8975020 · Received September 9, 2019

    Report

    Report Number
    0001825034-2019-03881
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 14, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI # (B)(4). COMPLAINT WAS CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW IDENTIFIED DISENGAGED/ FRACTURED FEMORAL STEM COMPONENT, WHICH RESULTED IN THE DISTAL COMPONENT TO BE MALORIENTED AND DISPLACED THE FEMORAL DIAPHYSIS. IT IS REPORTED THAT THE SCREW BACKED OUT DUE TO THE PATIENT FALLING; HOWEVER, IT IS UNKNOWN IF THE IMPLANTS CONTRIBUTED TO THE FALL. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 559570, EXPIRATION DATE - JAN 8, 2029, MANUFACTURE DATE ¿ JAN 8, 2019. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 559480, EXPIRATION DATE - MAR 5, 2029, MANUFACTURE DATE ¿ MAR 5, 2019. CONCOMITANT MEDICAL PRODUCTS: ITEM # 150410 LOT # 809110, ITEM # 150477 LOT # 771510, ITEM # 150476 LOT # 772820, ITEM # 150478 LOT # 321490, ITEM # 150480 LOT # 361570, ITEM # 150493 LOT # 021760, ITEM # 150354 LOT # 949080, ITEM # 150461 LOT # 559480, ITEM # 150394 LOT # 342520, ITEM # 184788 LOT # 148070, ITEM # 150424 LOT # 950770. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03882.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED PATIENT UNDERWENT KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO DISASSOCIATION AND SCREW BACKING OUT DUE TO FALL IN BATHROOM 4 WEEKS AFTER THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771548 OSS 3CM ELLIP DIAPHYSEAL SEG PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R