BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC XR MP FP T1 PPS 4X93MM

    MDR report key: 16545051 · Received March 15, 2023

    Report

    Report Number
    0001825034-2023-00452
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 28, 2023
    Report Date
    July 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304517417
    PMA / PMN Number
    K120030
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL, AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE ALSO REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE X-RAY RECORDS IDENTIFIED THE FOLLOWING: OVERALL FIT AND ALIGNMENT, AS WELL AS BONE QUALITY APPEARS NORMAL. THE ANGLE MEASUREMENTS CANNOT BE MADE ON THE PROVIDED IMAGE. THERE WERE NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, OR OTHER CONTRIBUTING FACTORS. THERE WAS NO CLEAR INDICATION IF THE SIZE OF THE IMPLANT HAD CAUSED THE FRACTURE. HOWEVER, IT WAS WELL NOTED THAT THE INTRAMEDULLARY COMPONENT OF THE LEFT HIP ARTHROPLASTY DOES NOT SIGNIFICANTLY EXTEND INTO THE SUBTROCHANTERIC DIAPHYSIS. WHEN COMPARED TO THE RIGHT TOTAL HIP ARTHROPLASTY, THE INTRAMEDULLARY COMPONENT IS SIGNIFICANTLY SMALLER. A REVIEW OF THE AVAILABLE MEDICAL INFORMATION IDENTIFIED THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT WAS "BUSHWALKING" OR HIKING AND FELL. THE PATIENT EXHIBITED A PERIPROSTHETIC FEMUR FRACTURE, PER THE X-RAY REVIEW, 5 WEEKS POSTOPERATIVELY. WITHIN THE FIRST 6 WEEKS POSTOPERATIVELY, THE GOAL IS STRENGTHENING, WALKING WITHOUT AN ASSISTIVE DEVICE, AND BALANCE TRAINING. IN THE FOLLOWING WEEKS, THE FOCUS IS ON ENDURANCE TRAINING, REGAINING FULL STRENGTH, AND PERFORMING OWN ADLS. IT IS NOT RECOMMENDED TO GO ON A HIKE OR BUSHWALKING ON UNEVEN SURFACES FOR THE BALANCE OF THE HIP IS NOT AT 100%. RECOMMENDATIONS MAY VARY INDIVIDUALLY BY PROVIDER; HOWEVER, TYPICALLY THIS TYPE OF ACTIVITY WOULD NOT BE RECOMMENDED SO EARLY IN THE RECOVERY. THE REPORTED ISSUE WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR, AS IT IS NOT RECOMMENDED TO WALK ON UNEVEN SURFACES FOR THE BALANCE OF THE HIP IS NOT AT 100% WITHIN THE FIRST 6 WEEKS POSTOPERATIVELY. 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: CAT# 650-0663 LOT# 2020021213 DELTA CERAMIC FEM HD 36/+6MM. CAT# 110010243 LOT# 7332485 G7 OSSEOTI 3 HOLE SHELL 50MM D. CAT# 010000934 LOT# 7057187 G7 HI-WALL E1 LINER 36MM D. REPORT SOURCE: FOREIGN: COUNTRY: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ARTHROPLASTY. THE SURGEON INDICATED THAT IT HAD BEEN A DIFFICULT PROCEDURE. THE BROACHING WAS CHALLENGING (WOODPECKER USED), AND DISTAL CANAL REAMING WAS REQUIRED. A SMALL FEMORAL IMPLANT WAS USED DUE TO TYPE A FEMUR. FORMUS PLANNING WAS UTILIZED FOR THIS CASE. APPROXIMATELY 2 MONTHS LATER, THE PATIENT FELL WHILE BUSHWALKING, AND PRESENTED IN THE EMERGENCY DEPARTMENT WITH A PERIPROSTHETIC OF THE LEFT FEMUR VANCOUVER B (CALCAR SPLIT). THE PATIENT WAS THEN TRANSPORTED TO A DIFFERENT FACILITY AND THE HIP WAS SUBSEQUENTLY REVISED. THE SURGEON WAS HAPPY WITH THE FINAL REVISION, AND THERE WERE NO SURGICAL ISSUES. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835100 TPRLC XR MP FP T1 PPS 4X93MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6228185 00880304517417

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R