BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD, M, 36/0, TAPER 12/14

    MDR report key: 16625447 · Received March 28, 2023

    Report

    Report Number
    0009613350-2023-00123
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 4, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LPH
    UDI-DI
    00889024386495
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES: CONSTRAINED LINER WITH CONSTRAINING RING; ITEM# 00-6334-068-36; LOT# 60869003. FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS; ITEM# 00-9982-018-18; LOT# 61384910. FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS; ITEM# 00-9982-018-23; LOT# 61195655. FEMORAL BODY - REVISION - NITRIDED - POROUS CEMENTLESS; ITEM# 00-9990-017-46; LOT# 60342487R. FEMORAL BODY - REVISION - NITRIDED - POROUS CEMENTLESS; ITEM# 00-9990-018-46; LOT# 60871375. CABLE CERCLAGE CABLE WITH CRIMP; ITEM# 00-2232-004-18; LOT# 61218419. CABLE CERCLAGE CABLE WITH CRIMP; ITEM# 0-2232-004-18; LOT# 61151241. CABLE CERCLAGE CABLE WITH CRIMP; ITEM# 00-2232-004-18; LOT# 61202484. CABLE CERCLAGE CABLE WITH CRIMP; ITEM# 00-2232-004-18; LOT# 61178767. CABLE CERCLAGE CABLE WITH CRIMP; ITEM# 00-2232-004-18; LOT# 61261179. REPORT SOURCE - FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, A3, B4, B5, D6, G3, G6, H1, H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. IT WAS CONFIRMED THAT THE REVISION OCCURRED DUE TO HIP STEM FRACTURE. AS THIS COMPLAINT ONLY CAPTURES THE HEAD IMPLANTED, NO PROBLEM WAS FOUND. IF ANY FURTHER INFORMATION IS FOUND 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 THERE WAS A REVISION FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 13 YEARS AFTER INITIAL SURGERY THE STEM WAS REVISED DUE TO IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9455 COCR HEAD, M, 36/0, TAPER 12/14 HIP PROSTHESIS LPH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2527653 00889024386495

    Patients

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