BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASE PLATE UNCEMENTED

    MDR report key: 13693620 · Received March 8, 2022

    Report

    Report Number
    0001822565-2022-00687
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024269101
    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

    (B)(4). DEVICE PRODUCT CODE - PHX. CONCOMITANT PRODUCTS: ITEM# 00434904011; LOT# 64032723. ITEM# 00434904000; LOT# 64560444. ITEM# 0104223036; LOT# 3043248. ITEM# 0104223042; LOT# 3021386. REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS SENT FOR PATHOLOGY TESTING. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE HISTOPATHOLOGY REPORTED MILD PALE HISTIOCYTIC INFILTRATE, SUGGESTIVE OF PROSTHESIS WEAR; DEGENERATIVE CHANGES; NO EVIDENCE OF INFECTION. THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION DOES NOT CHANGE. 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

    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. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE STERILE CERT WITHIN THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THAT THE DEVICES WERE STERILIZED PER SPECIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR LOOSENING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY ONE (1) YEAR AND ONE (1) MONTH POST-IMPLANTATION DUE TO SCREW FRACTURE AND LOOSENING OF BASEPLATE. ADDITIONALLY PATIENT HAD AN INFECTED SKIN LESION TREATED THREE (3) WEEKS PRIOR TO REVISION. SURGEON MENTIONED THAT INFECTED SKIN LESION AND THE FACT THE PATIENT IS A FARMER WITH HIGH PHYSICAL DEMANDS MAY HAVE CONTRIBUTED TO THE BASEPLATE LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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
    1926269 BASE PLATE UNCEMENTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 64556002 00889024269101

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H SEE NARRATIVE IN H10