BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR. LINER +5 SZ 25

    MDR report key: 14396795 · Received May 13, 2022

    Report

    Report Number
    0001825034-2022-01215
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    April 25, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00880304203549
    PMA / PMN Number
    K030047
    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 ADDITIONAL INFORMATION. D10: 103531- TI LOW PROFILE SCREW 6.5X20MM- 374180. 103534- TI LOW PROFILE SCREW 6.5X35MM- 212290. 103537- TI LOW PROFILE SCREW 6.5X50MM- 928020. 123741- 3/8-24 APICAL HOLE PLUG 1/CUP- 684860. 31-323230- 3.2MMX30MM RNGLC+ ACET DRL BIT- 449430. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). 14-107020- FRDM CNSTR HD 36MM T12/14 +6MM- 951239, UNKNOWN- UNKNOWN REGENEREX CUP- UNKNOWN, UNKNOWN-UNKNOWN STEM-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01216. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO DISLOCATION. DURING THE REVISION THE LINER, HEAD, AND CUP WERE REVISED. THE STEM REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395315 FREEDOM CONSTR. LINER +5 SZ 25 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 320100 00880304203549

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H