BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E

    MDR report key: 11947953 · Received June 7, 2021

    Report

    Report Number
    0001822565-2021-01561
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024510555
    PMA / PMN Number
    K121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING RELATED ANOMALIES/DEVIATIONS IDENTIFIED: (B)(4). DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. COMPLAINT IS NOT CONFIRMED. 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). CONCOMITANT DEVICES: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT USE WITH TIBIA SIZES E-F/CR FEMUR SIZES 8-11, CATALOG #:42512100810, LOT #: 64463461; FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS, CATALOG #: 42502806401, LOT #:63417244; PSN TM FEM/TMTIB/VE/TM/INS, CATALOG #: 98-0002-001-18, LOT #: N/I. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. HOSPITAL DID NOT RETURN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, WAS REVISED DUE TO PAIN IN HIS TIBIA. IT WAS DETERMINED THAT THE TM TIBIA WAS LOOSE. REVISED TO STANDARD CEMENTED COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845871 PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 64405777 00889024510555

    Patients

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