BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18/150 STEM EXT TRL BOW

    MDR report key: 18267215 · Received December 5, 2023

    Report

    Report Number
    1818910-2023-24579
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    January 1, 2023
    Report Date
    December 5, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295157946
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION, THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED, THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿WHEN I CLEAN THIS INSTRUMENT THE INSTRUMENTS RELEASE A LOT OF ¿BLUE PAINT¿ (SEE PICTURE BELOW)¿. THE PRODUCTS AND PHOTOS (IMAGE001) WERE RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE COMPLAINT UNIT WAS FORWARDED TO THE DEPUY MATERIAL SCIENCE LAB IN WARSAW FOR FURTHER INVESTIGATION. FURTHER DETAILS OF THE DEVICE'S ANALYSIS WERE ATTACHED ON "MATERIAL EVALUATION E2024-000878 (B)(4). VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT 18/150 STEM EXT TRL BOW EXHIBITS VARYING DEGREES OF FADING OF THE BLUE ANODIZING AND WHITE CHALKY APPEARANCE ON THE SURFACE. THE OBSERVED WHITE CHALKY APPEARANCE IS CONSISTENT WITH CORROSION OF THE ALUMINUM ALLOY. THESE OBSERVATIONS SUGGEST THE STEM WAS EXPOSED TO A CORROSIVE ENVIRONMENT OUTSIDE OF WHAT IS PERMITTED BY THE INSTRUCTIONS FOR USE (IFU-0902-00-721). THE STEM WAS LIKELY EXPOSED TO BASIC OR ACIDIC SOLUTIONS WHERE PH IS EITHER HIGH OR VERY LOW, RESPECTIVELY, OR TO AN ELECTROLYTIC SOLUTION WITH HIGH CHLORIDE CONCENTRATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE STEM EXT TRL BOW WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MAINTENANCE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H10 ADDITIONAL NARRATIVE: CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: WHEN I CLEAN THIS INSTRUMENT THE INSTRUMENTS RELEASE A LOT OF ¿BLUE PAINT¿ (SEE PICTURE BELOW). THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTO WAS PROVIDED FOR REVIEW. SEE ATTACHMENT (IMAGE001). THE PHOTO INVESTIGATION FOUND THAT THE ANODIZED COATING IS COMPROMISED DUE TO THE IMAGE SHOWING Q-TIPS WITH BLUE INK. THE ANODIZED COLOR IS TIGHTLY BOUND TO THE ALUMINUM SURFACE AND DOES NOT EASILY BLEED OR TRANSFER UNDER NORMAL CONDITIONS OF USE. THE COLOR ITSELF IS INTEGRALLY BONDED TO THE OXIDE LAYER, ENSURING THAT IT REMAINS STABLE AND DOES NOT SEEP OR BLEED ONTO OTHER SURFACES. HOWEVER, IT'S IMPORTANT TO NOTE THAT EXTREME CONDITIONS, SUCH AS EXPOSURE TO HARSH CHEMICALS, HIGH TEMPERATURES, OR ABRASIVE CLEANING METHODS, CAN POTENTIALLY AFFECT THE INTEGRITY OF THE ANODIZED COLOR FINISH. ADDITIONALLY, IMPROPER HANDLING OR SURFACE DAMAGE MAY COMPROMISE THE ANODIZED SURFACE, POTENTIALLY AFFECTING ITS COLOR STABILITY. TO MAINTAIN THE LONGEVITY AND APPEARANCE OF AN ANODIZED FINISH, IT IS RECOMMENDED TO FOLLOW THE IFU (IFU-0902-00-721 ) FOR CLEANING AND CARE TO MINIMIZE THE RISK OF COLOR BLEEDING OR ANY UNINTENDED COLOR CHANGES DURING MAINTENANCE. POTENTIAL CAUSE IS TRACED TO MAINTENANCE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED. AS THE OBSERVED CONDITION OF THE [18/150 STEM EXT TRL BOW ] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE.  BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PAINT IS COMING OFF THE FEMORAL TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177737 18/150 STEM EXT TRL BOW JRN : FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US AF1680505 10603295157946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown