BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLEN POST REGENEREX

    MDR report key: 15914633 · Received December 5, 2022

    Report

    Report Number
    0001825034-2022-02705
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    November 8, 2022
    Report Date
    March 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304459854
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS: 0001825034-2022-02707 AND 0001825034-2022-02706. MEDICAL PRODUCTS: ITEM#: 113921, PRODUCT TYPE: BIO-MOD 44X17MM HD 4MM OFFSET; LOT#: 286920. ITEM#: 113954, PRODUCT TYPE: MD HYBRID GLENOID BASE 4MM; LOT#: 170890. ITEM#: 110027734, PRODUCT TYPE: COMP VRS IMPLT W MI TPR ADPTR; LOT#: 936040. ITEM#: 110031378, PRODUCT TYPE: VERSA-DIAL TAPER ADAPTOR 25MM; LOT#: 936090. ITEM#: 115396, PRODUCT TYPE: COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 989070. ITEM#: 180554, PRODUCT TYPE: COMP LK SCR 3.5HEX 4.75X35 ST, LOT#: 037790. ITEM#: 180555, PRODUCT TYPE: COMP LK SCR 3.5HEX 4.75X40 ST, LOT#: 100270. ITEM#: 180554, PRODUCT TYPE: COMP LK SCR 3.5HEX 4.75X35 ST, LOT#: 987960. ITEM#: 110030776, PRODUCT TYPE: 40MM VERSA-DIAL GLEN STD, LOT#: 65386046. ITEM#: 110031399, PRODUCT TYPE: HMRL TRAY STD, LOT#: 65337908. ITEM#: 110031427, PRODUCT TYPE: HMRL BEARING 40 MM STD VITE, LOT#: 64980844. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL DISCARDED THE PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02707-1. 0001825034-2022-02706-1. H6: COMPONENT CODES: MECHANICAL (G04) - STEM. NO PHOTOS WERE PROVIDED, VISUAL EXAMINATION COULD NOT BE PREFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING ASSESSMENT OF IMAGING: A RIGHT SHOULDER ARTHROPLASTY IS PRESENT. THERE IS MARKED SUPERIOR POSITION OF THE HUMERAL IMPLANT IN RELATION TO THE GLENOID IMPLANT CONSISTENT WITH A SEVERE ROTATOR CUFF TEAR. LUCENCY ALONG THE GLENOID IMPLANT FIXATION IS CONSISTENT WITH IMPLANT LOOSENING. THERE IS NO EVIDENCE OF HUMERAL IMPLANT LOOSENING. THE GLENOID APPEARS LOOSE AS NOTED, RADIOLUCENCY IS PRESENT. THERE IS MALALIGNMENT WITH SUPERIOR POSITION OF THE HUMERAL IMPLANT IN RELATION TO THE GLENOID. BONE QUALITY IS OSTEOPENIC. THE LOOSENING AND ROTATOR CUFF TEAR WITH MIGRATION WOULD LEAD TO REVISION TO A REVERSE TYPE SYSTEM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A TEAR OF THE ROTATOR CUFF. FURTHER, THE PATIENT HAD LOOSENING OF THE GLENOID COMPONENT AND DISLOCATION OF THE POLYETHYLENE FROM THE POST IMPLANT.

    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
    1471391 PT HYBRID GLEN POST REGENEREX PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. PT-113950 497560 00880304459854

    Patients

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