BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 16036665 · Received December 22, 2022

    Report

    Report Number
    0001825034-2022-02830
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 30, 2022
    Report Date
    March 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K143697
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 856135040. LOT NUMBER - 313190. EXPIRATION DATE - JUN 17, 2029. UDI- (B)(4). MANUFACTURE DATE ¿ JUN 17, 2019. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 856135028. LOT NUMBER ¿ 002740. EXPIRATION DATE - APR 8, 2032 UDI- (B)(4). MANUFACTURE DATE ¿ APR 8, 2022. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 856135024 LOT NUMBER - 664870. EXPIRATION DATE - APR 28, 2031. UDI- (B)(4). MANUFACTURE DATE ¿ APR 28, 2021. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 856135024 LOT NUMBER ¿ 373450. EXPIRATION DATE - APR 3, 2029. UDI- (B)(4). MANUFACTURE DATE APR 3, 2019. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 856135018 LOT NUMBER - 299440. EXPIRATION DATE - JAN 9, 2030. UDI- (B)(4). MANUFACTURE DATE ¿ JAN 9, 2020. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 856135016 LOT NUMBER - 421600. EXPIRATION DATE - JUN 13, 2029. UDI- (B)(4). MANUFACTURE DATE ¿ JUN 13, 2019. ADDITIONAL ASSOCIATED PRODUCTS & MDR: MDR: 0001825034-2022-02829. ITEM# 851318203; LOT# 990140. ADDITIONAL ASSOCIATED PRODUCTS: ITEM# 851235024; LOT# 436560. ITEM# 851235026; LOT# 988770. ITEM# 851218000; LOT# 593920.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; 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: COMMINUTED TRANSCONDYLAR FRACTURE OF THE DISTAL LEFT HUMERUS WITH PLATE AND SCREW FIXATION RADIALLY. FRACTURED PLATE IS SEEN ON THE IMAGE LABELED EVENT WITHOUT DISLOCATION. WITHDRAWN SCREW IS SEEN ALONG THE DISTAL ASPECT OF THE PROXIMAL FRACTURE PLATE FRAGMENT WITH POSSIBLE LOOSENING OF THE SCREW PROXIMAL TO THIS. IMAGES LABELED EVENT DEMONSTRATES SOME BONY CALLUS FORMATION WITH LUCENT FRACTURE LINE STILL SEEN. HEAVY LIFTING MAY HAVE CONTRIBUTED TO THIS COMPLICATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. PATIENT NON-COMPLIANCE WAS NOTED AS A HEAVY OBJECT WAS LIFTED. HOWEVER, IT WAS ALSO INDICATED THAT THE SCREW BACKED OUT AT SOME TIME LIKELY PRIOR TO THE PLATE FRACTURE THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED REPORTS: 0001825034-2022-02829-1.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT LEFT ELBOW REVISION THREE MONTHS POST IMPLANTATION DUE TO MIGRATION OF A SCREW AND FRACTURED PLATE. IT WAS NOTED ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S PLATE.

    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
    2826828 PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H