BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL 133 T1 PPS HO 18X156MM

    MDR report key: 22017434 · Received May 14, 2025

    Report

    Report Number
    0001825034-2025-01396
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 28, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304499263
    PMA / PMN Number
    K200196
    Adverse Event
    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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: G3; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND NOT SUBMITTED TO MMI AS THE FINDINGS WERE DOCUMENTED WITHIN THE MEDICAL RECORDS. SUBMISSION WOULD NOT ENHANCE THE INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORD FINDINGS. 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). SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. D10: CAT# 650-1058 LOT# 3211451 CER BIOLOXD OPTION HD 40MM. CAT# 650-1065 LOT# 3213185 CER OPTION TYPE 1 TPR SLEVE -3. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: A1; B5; B7; E1; G3; H2; H6. D10: CAT# 00620206022 LOT# 63315618 SHELL POROUS WITH CLUSTER HOLES 60 MM CAT# 00630506040 LOT# 65738940 LINER STANDARD 3.5 MM OFFSET 40 MM I.D. FOR USE WITH 60 MM O.D. SHELL. CAT# 00625006540 LOT# J7431796 BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH. CAT# 00625006525 LOT# J7882572 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 WEEKS LATER DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, DEVELOPED NUMBNESS, INCREASING PAIN, SWELLING AND AMBULATION DIFFICULTIES. RADIOGRAPHIC IMAGING DISPLAYED FEMORAL STEM SUBSIDENCE WITH A GREATER TROCHANTER FRACTURE. APPROXIMATELY 2 WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION WHERE A HEMATOMA WAS EVACUATED AND THE FEMORAL FRACTURE WAS IDENTIFIED, INCLUDING ONE MAJOR FRACTURE FRAGMENT. THE STEM, TAPER, AND HEAD WERE REVISED, AND THE FRACTURE WAS FIXATED WITH A PLATE AND SIX CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183100 TAPERLOC COMPLETE PRIMARY FEMORAL 133 T1 PPS HO 18X156MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 7617577 00880304499263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.