BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM I.D. 46MM O.D. SIZE G BEARING

    MDR report key: 16911910 · Received May 11, 2023

    Report

    Report Number
    0001822565-2023-01227
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 1, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572713
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: (B)(6)¿ G7 SHELL ¿ 6972077. (B)(6)¿ G7 DUAL MOBILITY LINER ¿ 567810. (B)(6)¿ BIOLOX DELTA HEAD ¿ 3072051. (B)(6)¿ MODULAR NECK ¿ 64516637. (B)(6)¿ MODULAR STEM ¿ 64960505. PRODUCT WILL NOT BE RETURNING TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS KEPT BY THE PATIENT. 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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED GOUGES TO THE RIM OF THE DUAL MOBILITY BEARING AND BIO-DEBRIS. GOUGES WERE ALSO NOTED TO THE KINECTIV NECK AND INNER SPHERICAL SURFACE OF THE DUAL MOBILITY LINER. NO FURTHER EVALUATION CAN BE MADE TO THE PROVIDED PICTURES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO 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 THAT PATIENT UNDERWENT NOTED EXPERIENCING PAIN AND ELEVATED METAL ION LEVELS. IT WAS FOUND THAT THE CERAMIC DUAL MOBILITY HEAD HAD DISASSOCIATED FROM THE HEAD CAUSING THE STEM TO ARTICULATE ON THE DUAL MOBILITY LINER. THE PATIENT ULTIMATELY UNDERWENT A REVISION SURGERY APPROXIMATELY 16 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637686 28MM I.D. 46MM O.D. SIZE G BEARING PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64782999 00889024572713

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R SEE H10