BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 11X142MM 2MM T1

    MDR report key: 13758646 · Received March 14, 2022

    Report

    Report Number
    0001825034-2022-00407
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    February 7, 2022
    Report Date
    April 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    UDI-DI
    00880304489714
    PMA / PMN Number
    K200196
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES CONTRALATERAL HIP PERFORMED, INCREASE IN PAIN WITH AMBULATION, X-RAY SHOWS RADIOLUCENCY AROUND STEM, NO INGROWTH WAS NOTED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF (B)(4), LOT 6601603, G7 SHELL; REF (B)(4), LOT 64495274, SCREW; REF (B)(4), LOT 64563153, SCREW; REF (B)(4), LOT 948540, DM LINER; REF (B)(4), LOT 560940, DM BEARING; REF (B)(4), LOT 2983045, BIOLOX HEAD; REF (B)(4), LOT 6551317, TAPERLOC STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 2 YEARS LATER DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM, PAIN AND DIFFICULTY AMBULATING. DURING THE REVISION, A LACK OF IN-GROWTH ON THE FEMORAL STEM WAS NOTED. THE STEM, HEAD, AND LINER WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281490 TPRLC 133 T1 PPS HO 11X142MM 2MM T1 PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 6551317 00880304489714

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R