BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BA BIO 28MM 12/14 + 8.5

    MDR report key: 17433777 · Received August 1, 2023

    Report

    Report Number
    1818910-2023-15632
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 17, 2023
    Report Date
    August 1, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 WHICH 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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT NUMBER: 9111123, LOT NUMBER: 4165119 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION RECEIVED, ¿THE CERAMIC HEAD BROKE SPONTANEOUSLY DURING REHABILITATION. THE PATIENT CAME IN CONSULTATION TO COMPLAIN OF A STRANGE NOISE AT THE LEVEL OF HIS PROSTHESIS. DURING RECOVERY SURGERY, IT IS OBSERVED THAT THE CERAMIC HEAD IS FRACTURED AND HAS IMPLODED INSIDE THE POLYETHYLENE. PATIENT CONSEQUENCE : NEW SURGERY FOR THE PATIENT". THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE ALONG WITH SUPPLIER INVESTIGATION PERFORMED BY SUPPLIER. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT FRAGMENTS OF A CERAMIC FEMORAL HEAD WERE FIXATED IN A COMPETITORS BIPOLAR SHELL. METAL TRANSFER OF ERRATIC APPEARANCE WERE OBSERVED ON THE POLISH SURFACE AND ON THE FRACTURE AREAS. THIS SECONDARY METAL WAS PROBABLY PRODUCED BY CHAFING BETWEEN THE METAL PART AND THE CERAMIC FRAGMENTS AFTER THE PRIMARY FRACTURE EVENT AND DURING THE SURGICAL PROCEDURES. ADDITIONALLY, THIN CONCENTRIC LINES WERE NOT FOUND EQUALLY DISTRIBUTED ON THE CONICAL BORE SURFACE. THIS INDICATES THAT THE INTERFACE WAS DISTURBED DURING THE ASSEMBLY OF THE FEMORAL HEAD AND STEM, POTENTIALLY CAUSES BY CONTAMINATION. SUCH DISTURBANCES CAN LEAD TO DECREASE OF THE BURST STRENGTH OF THE FEMORAL HEAD. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE FEMORAL HEAD FAILURE CANNOT BE TRACED TO DESIGN OR MANUFACTURING, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED DUE TO THERE BEING MULTIPLE FACTORS THAT MAY CONTRIBUTED TO THE FRACTURE. CONSIDERATION MUST BE GIVEN TO ALL POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. IT IS HIGHLY RECOMMENDED TO THE PATIENT TO CONSULT WITH THEIR HEALTHCARE PROFESSIONAL FOR FURTHER ASSESSMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [9111123 / 4165119] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HIP BA BIO 28MM 12/14 + 8.5 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 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 CERAMIC INSERT BELONGS TO THE SHOP ORDER (B)(4) . PROTOCOLS AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE FEMORAL HEAD CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [9111123 / 4165119] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CERAMIC HEAD BROKE SPONTANEOUSLY DURING REHABILITATION. THE PATIENT CAME IN CONSULTATION TO COMPLAIN OF A STRANGE NOISE AT THE LEVEL OF HIS PROSTHESIS. DURING RECOVERY SURGERY, IT IS OBSERVED THAT THE CERAMIC HEAD IS FRACTURED AND HAS IMPLODED INSIDE THE POLYETHYLENE. PATIENT CONSEQUENCE : NEW SURGERY FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843520 HIP BA BIO 28MM 12/14 + 8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY ORTHOPAEDICS INC US 4165119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN HIP ACETABULAR LINERS