BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 14.0

    MDR report key: 15091878 · Received July 25, 2022

    Report

    Report Number
    0001825034-2022-01700
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 1, 2022
    Report Date
    September 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304513518
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110017108 ¿ G7 SHELL ¿ 64849765; 30123608 ¿ G7 VIT E LINER ¿ 64849765; 650-1057 ¿ BIOLOX HEAD ¿ 3062933; 650-1067 ¿ BIOLOX TAPER ¿ 307230. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H6: COMPONENT CODE MECHANICAL (G04) ¿ STEM. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: OVERALL IMPLANT FIT AND ALIGNMENT ARE ANATOMIC. BONE QUALITY APPEARS NORMAL. NO SIGNS OF MALALIGNMENT, LOOSENING, OR WEAR. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION WAS REQUESTED AND SENT TO THE CUSTOMER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 MONTHS POST IMPLANTATION DUE TO PROGRESSIVE PAIN. DURING THE SURGERY, IT WAS NOTED THAT THE STEM APPEARS TO HAVE POTTED DUE TO EXCESSIVE PPS SPRAY AT THE REDUCED DISTAL PORTION OF THE STEM. THE STEM AND HEAD WERE REMOVED AND REPLACED. 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
    115771 TPRLC 133 MP TYPE1 PPS HO 14.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6806775 00880304513518

    Patients

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