BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLEN POST REGENEREX

    MDR report key: 6995664 · Received November 2, 2017

    Report

    Report Number
    0001825034-2017-09659
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 4, 2017
    Report Date
    March 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: SM HYBRID GLENOID BASE 4MM CAT#:113952 LOT#: 599210, VERSA-DIAL/COMP TI STD TAPER CAT#:118001 LOT#:178200, VERSA-DIAL 38X19X39 HUMERAL HEAD CAT#:113022 LOT#:79200. THE REPORTED EVENT IS CONFIRMED. PRODUCTS WERE RETURNED; REVIEW OF THE SEM ANALYSIS IDENTIFIED THAT THE RETURNED PRODUCT SHOWED FRACTURE TO THE POST. IN THIS CASE, THESE FRACTURE SURFACES WERE ENTIRELY OBSCURED BY POST-FRACTURE DAMAGE. THEREFORE, THE FRACTURE INVESTIGATION WAS INCONCLUSIVE. THE FRACTURE SURFACES ON THE CENTRAL CORE OF THE POLYETHYLENE ARE THE REGIONS OF PRIMARY INTEREST FOR FRACTURE INVESTIGATION. THE REGENEREX PORTION OF THE CONSTRUCT HAS A FEW ISOLATED EXAMPLES OF FRACTURED SINTER NECKS WHICH REMAINED INTACT; BRITTLE FRACTURE AND IN ONE CASE A POSSIBLE LOW-CYCLE BENDING FATIGUE WITH CRACK ARREST LINES. HOWEVER, THESE ARE LIKELY SECONDARY FRACTURE SURFACES PROVIDING NO ROOT CAUSE OF FRACTURE. MATERIALS WERE DETERMINED TO BE CONFORMING TO SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE REVIEWED, AS LOT NUMBER IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113952, SM HYBRID GLENOID BASE 4MM, 599210. REPORT SOURCE, FOREIGN: EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09660.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND A BROKEN IMPLANT. THE SHOULDER WAS REVISED TO A HEMI SHOULDER, AND BONEGRAFT WAS USED TO FILL THE PATIENT'S GLENOID. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS A AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776123 PT HYBRID GLEN POST REGENEREX PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 178200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R