BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMI HEAD 50MM

    MDR report key: 22323198 · Received June 24, 2025

    Report

    Report Number
    3005975929-2025-00063
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 13, 2025
    Report Date
    July 31, 2025
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    KWL
    UDI-DI
    00885556071205
    PMA / PMN Number
    K062408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT HAVE NOT BEEN RETURNED FOR EVALUATION. WITHOUT A DEFINITIVE BATCH NUMBER, A COMPLETE REVIEW OF THE HISTORICAL COMPLAINTS DATA CANNOT BE PERFORMED FOR THE ALLEGED DEVICES. A REVIEW OF HISTORICAL COMPLAINTS DATA WAS PERFORMED USING THE PART NUMBERS AND THE REPORTED FAILURE MODES TO EVALUATE PATTERNS OF REPEATED FAILURES OR DEFECTS. SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED FOR THE HEAD. NO SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED FOR THE SLEEVE. THIS FAILURE WILL CONTINUE TO BE MONITORED VIA ROUTINE TRENDING. AS NO DEVICE BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. THE REVIEW OF THE MOST RECENT IFU FOUND ADEQUATE WARNINGS AND PRECAUTIONS IN RELATION TO THE ALLEGED FAILURE MODES. A RISK MANAGEMENT REVIEW WAS PERFORMED. THE ALLEGED FAILURE MODES AND ASSOCIATED RISKS HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF HISTORIC ESCALATION ACTIONS RELATED TO THE PRODUCTS AND SIMILAR COMPLAINT EVENTS WAS PERFORMED. FOLLOWING THE REVIEW, PRIOR APPLICABLE ESCALATION ACTIONS WERE IDENTIFIED AND CONFIRMED TO REDUCE ASSOCIATED RISKS AS FAR AS POSSIBLE. NO FURTHER ESCALATION ACTIONS ARE REQUIRED. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. THE HETEROTOPIC OSSIFICATION (HO) IS A KNOWN RISK OF HIP JOINT SURGERY. IT CANNOT BE CONCLUDED THE HO IS ASSOCIATED WITH A MAL PERFORMANCE OF THE IMPLANT. THE ELEVATED COBALT, TAPER CORROSION AT THE HEAD NECK JUNCTION, CLOUDY SYNOVIAL FLUID AND METAL STAINING OF THE SYNOVIAL TISSUE ARE CONSISTENT WITH THE REPORTED METALLOSIS. HOWEVER, THE CLINICAL ROOT CAUSE OF THE METALLOSIS CANNOT BE DEFINITIVELY CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT ARE EXCESSIVE PHYSICAL ACTIVITY LEVELS, UNREASONABLE STRESS ON REPLACEMENT SYSTEM, EXCESSIVE PATIENT WEIGHT, TRAUMA TO THE JOINT REPLACEMENT, LOOSENING OF COMPONENTS MAY INCREASE PRODUCTION OF WEAR PARTICLES AND ACCELERATE DAMAGE TO THE BONE. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE AND PREVENTATIVE ACTIONS IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A RIGHT BHR-THA HAD BEEN PERFORMED ON (B)(6) 2008, PATIENT EXPERIENCED FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METALLOSIS. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY AND THE HEMI HEAD 50MM AND THE MODULAR SLEEVE WERE EXPLANTED. IN ADDITION, DURING PROCEDURE, THE HIP WAS ASPIRATED, AND 10 CC OF CLOUDY SYNOVIAL FLUID ENCOUNTERED, CONSISTENT WITH METALLOSIS. THE CAPSULE WAS MARKEDLY THICKENED, AND DISTORTED ANATOMY WAS ENCOUNTERED GIVEN PRIOR POSTERIOR APPROACH HIP REPLACEMENT WITH SUBSEQUENT METALLOSIS. THICKENED CAPSULE WAS DEBRIDED ON THE UNDERSURFACE. THE SUPERFICIAL CAPSULE WAS TAGGED AND RETRACTED SUPERIORLY. A EXOFIN DRESSING WAS APPLIED, FOLLOWED BY A STERILE DRESSING. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TAKEN TO THE PACU IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567381 HEMI HEAD 50MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN 00885556071205

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R ACETLR CUP HAP 58 MM W/ IMPTR: 74120158, UNKNOWN| MODULAR SLEEVE +8 MM 12/14: 74222400, UNKNOWN| UNKNOWN SYNERGY HIP STEM