BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 PPS HO 17.0

    MDR report key: 16691684 · Received April 6, 2023

    Report

    Report Number
    0001825034-2023-00762
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    December 3, 2018
    Report Date
    April 8, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304499157
    PMA / PMN Number
    K200196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. H6: COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT CONFIRMED BASED ON REVIEW OF MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SHORT LEG DEFORMITY RIGHT HIP, TRENDELENBURG LURCH. COMPONENT SUBSIDENCE OF RIGHT FEMUR, BONE INGROWTH. STABLE WELL FIXED FEMORAL COMPONENT. WELL POSITIONED AND WELL-FIXED ACETABULAR COMPONENT. RIGHT LEG MEASURED 14MM OF LEG LENGTH DISCREPANCY WITH THE LEFT. TAPER WAS UNDAMAGED AND SHOWED NO SIGNS OF CORROSION. NO PAIN. 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: 650-1057 CER BIOLOXD OPTION HD 36MM LOT NUMBER 2904520, 650-1066 CER OPT TYPE 1 TPR SLEVE 0MM LOT NUMBER 2920994, 010000860 G7 NEUTRAL E1 LINER 36MM H LOT NUMBER 6109006, 110017108 G7 FINNED 4 HOLE SHELL 62H LOT NUMBER 3972309. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 COMPONENT CODE: MECHANICAL (G04) - STEM. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: HEALED WELL, NO PAIN 5 YEARS POST OPERATION. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PT UNDERWENT A REVISION PROCEDURE 9 MONTHS POST-IMPLANTATION DUE TO AN UNDERSIZED STEM WITH MINOR SUBSIDENCE. THE FEMORAL HEAD AND ACETABULAR LINER WERE REPLACED. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532351 TPRLC 133 FP TYPE1 PPS HO 17.0 PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 3661564 00880304499157

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H