BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 5.0X130

    MDR report key: 23777885 · Received December 11, 2025

    Report

    Report Number
    0001825034-2025-03948
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    May 29, 2017
    Report Date
    December 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. D10: CAT# 650-1057 LOT# 749730 CER BIOLOXD OPTION HD 36MM. CAT# 650-1066 LOT# 330010 CER OPT TYPE 1 TPR SLEVE 0MM. CAT# 00875705602 LOT# 63445034 56MM O.D. SIZE KK POROUS UNCEMENTED WITH MULTI-HOLES SHELL USE WITH KK LINERS. CAT# 00875201236 LOT# 63276391 36MM I.D. SIZE KK ELEVATED RIM LINER USE WITH 56MM O.D. SIZE KK SHELL. CAT# 00625006540 LOT# 63551056 BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH. CAT# 00625006525 LOT# 63523390 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH. G2: FOREIGN: CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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: D4; G3; H2; H3; H4; H6. THE REPORTED EVENT OF DEEP/UNSPECIFIED INFECTION OCCURRED <90 DAYS POST IMPLANTATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. A SEROMA IS A POCKET OF CLEAR SEROUS FLUID THAT SOMETIMES DEVELOPS IN THE BODY AFTER SURGERY. THIS FLUID IS COMPOSED OF BLOOD PLASMA THAT HAS SEEPED OUT OF RUPTURED SMALL BLOOD VESSELS AND INFLAMMATORY FLUID PRODUCED BY THE INJURED AND DYING CELLS. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. THIS DEVICE IS USED FOR TREATMENT. THIS IS A LIMITED INVESTIGATION, AS PER (B)(4), A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION APPROXIMATELY 10 YEARS LATER DUE TO A PSEUDOTUMOR. SUBSEQUENTLY, ONE-WEEK POST-REVISION, PATIENT UNDERWENT AN I&D FOR A SUSPECTED INFECTION AND DURING THE PROCEDURE ENCOUNTERED A SEROMA. ALL IMPLANTS WERE RETAINED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604229 TAPERLOC POR LAT FMRL 5.0X130 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 138000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.