BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM ÿ 130MM LENGTH HUMERAL STEM

    MDR report key: 16196873 · Received January 18, 2023

    Report

    Report Number
    0001822565-2023-00148
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 23, 2022
    Report Date
    May 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024268951
    PMA / PMN Number
    K130661
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION, ADDITIONAL INFORMATION AND DEVICE EVALUATION. PROPOSED ANNEX G CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RELATIVE RADIOLUCENCY OF THE GLENOID SUGGESTS SEVERE OSTEOPENIA. HOWEVER, NO DEFINITE FRACTURE CAN BE SEEN. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED LOOSENING MENTIONED IN THE COMPLAINT DESCRIPTION WAS REFERENCING THE BASEPLATE, NOT THE STEM. THE BASEPLATE WILL BE REPORTED UNDER 0001822565-2023-01188. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). COMMON DEVICE NAME: PHX. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL WILL NOT RELEASE THE PRODUCT. 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. ASSOCIATED PRODUCTS AND REPORTS; 0001822565-2023-00149 ITEM#00436003600; LOT#65356130, 0001822565-2023-00152 ITEM#00434903603; LOT#65352850. OTHER ASSOCIATED PRODUCTS: ITEM#00436202000; LOT#64390359N, ITEM#47436108300; LOT#56672638, ITEM#0104223033; LOT#3021582, ITEM#0104223042; LOT#3127010, ITEM#47430906125; LOT#65267726, ITEM#47430904601; LOT#65157507 AND ITEM#47430902501; LOT#65553821.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED LOOSENING MENTIONED IN THE COMPLAINT DESCRIPTION WAS REFERENCING THE BASEPLATE, NOT THE STEM. THE BASEPLATE WILL BE REPORTED UNDER 0001822565-2023-01188.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY TWO (2) WEEKS POST IMPLANTATION DUE POOR BONE QUALITY, DISLOCATION, AND FIXATION OF IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822109 12MM ÿ 130MM LENGTH HUMERAL STEM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65538166 00889024268951

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R