BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA CER HEAD 12/14 36MM +12

    MDR report key: 21480896 · Received February 27, 2025

    Report

    Report Number
    1818910-2025-03164
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    February 1, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    PMA / PMN Number
    P070026
    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 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 THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: WHEN A STEM WAS PLACED, THE SURGEON WHO ARRIVED AT THE HEAD TRIALS ENCOUNTERED NO PROBLEMS, AND WHEN THE IMPLANT WAS PLACED ON THE STEM CONE, THE HEAD DID NOT IMPACT AS USUAL/ IT WOULD SEEM THAT THE COLLAR DEPTH IS SHORTER THAN THE LONG COLLAR. AS A RESULT, OPERATING TIME WAS EXTENDED. THE DECISION WAS MADE TO SWITCH TO A LONG- COLLAR HEAD 1365 36330 DIAM 36+8.5MM IN THESE CIRCUMSTANCES. THE CHOICE FELL ON FINDING THE BEST COMPROMISE BETWEEN BENEFIT AND PATIENT RISK. STAYING WITH THIS IMPLANT, WHICH IS AFFECTED BY THE PROBLEM, MEANS WE RUN THE RISK OF FRACTURING THE CERAMIC IF IT IS NOT IMPACTED UNDER THE CONDITIONS. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION REVEALED THE DELTA CER HEAD 12/14 36MM +12 HAD SIGNS OF BEING TRIED TO IMPLANT, METAL TRANSFER PATTERNS OBSERVED MAINLY IN THE INNER FIXATION AREA OF THE DEVICE CONSISTENT WITH THE IMPLANTATION ATTEMPTS. HOWEVER NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136536340/ 4130626] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. ADDITIONALLY, THE SUPPLIER PERFORMED A REVIEW FOR THE PROTOCOLS AND ACCEPTANCE CERTIFICATE, THE DIMENSIONS WERE WITHIN THE SPECIFIED TOLERANCE A DIMENSIONAL INSPECTION WAS PERFORMED AND MET SPECIFICATIONS*. GIVEN THE EVIDENCE REVIEWED, THE REPORTED ALLEGATION CANNOT BE CONFIRMED. A FUNCTIONAL EVALUATION WAS NOT PERFORMED AS THE MATING COMPONENT WAS NOT RETURNED FOR EVALUATION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER HEAD 12/14 36MM +12 WOULD HAVE NOT CONTRIBUTED 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 J&J MEDTECH ORTHOPAEDICS 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. DRAWING/SPECIFICATIONS REVIEWED? DWG-136536340 REV. E CURRENT. DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS. DEVICE LENGTH = 29.60 MM ± 0.15 MM. DEVICE WIDTH Ø = 35.975 MM ± .025 MM. FIXATION WIDTH Ø = 13.42 MM. WIDTH ON TAPER AREA (SMALLER PORTION) Ø = 13.178 MM. MEASURED DIMENSIONS: DEVICE LENGTH = 29.65 MM (COMPLIES). DEVICE WIDTH Ø = 35.93 MM (COMPLIES). FIXATION WIDTH Ø = 13.42 MM (COMPLIES). WIDTH ON TAPER AREA (SMALLER PORTION) Ø = 13.18 MM (COMPLIES). DEVICE USED: DIGIMATIC CALIPER CD78619. VERMONT GAGE (102100400). DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136536340/ 4130626] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ABY PRE-EXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136536340/ 4130626] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ABY PRE-EXISTING MATERIAL DEFECT. ADDED: B5. CORRECTED: H3.

    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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. H11 ADDITIONAL NARRATIVE: ADDED: H6 HEALTH EFFECT (IMPACT AND CLINICAL CODE). IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. WHEN IMPLANTING THE DEVICE DIAM 36+ 12 REF 1365.36340 LOT 4130626 EXP 31/MAR/2028. THE SURGEON ARRIVED AT THE HEAD TESTS DID NOT ENCOUNTER ANY PROBLEMS AND WHEN IMPLANTING THE DEVICE ON THE CONE OF THE STEM, THE HEAD DID NOT IMPACT AS USUAL / IT SEEMS THAT THE DEPTH OF THE NECK IS SHORTER THAN THE LONG NECK. THE SURGERY TIME WAS ACTUALLY LENGTHENED. THE DECISION WAS DIRECTED TO PASS ON A LONG NECK HEAD 1365.36330 DIAM 36+8.5MM IN THESE CIRCUMSTANCES. THE CHOICE WAS TO FIND THE BENEFIT / PATIENT RISK COMPROMISE. REMAINED ON THIS IMPLANT CONCERNED BY THE PROBLEM LEADS US TO TAKE A RISK OF FRACTURE OF THE CERAMIC IF IT IS NOT IMPACTED UNDER THE CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN A STEM WAS PLACED, THE HEAD TRIALS ENCOUNTERED NO PROBLEMS, AND WHEN THE IMPLANT WAS PLACED ON THE STEM CONE, THE HEAD DID NOT IMPACT AS USUAL. IT WOULD SEEM THAT THE COLLAR DEPTH IS SHORTER THAN THE LONG COLLAR. AS A RESULT, OPERATING TIME WAS EXTENDED. THE DECISION WAS MADE TO SWITCH TO A LONG- COLLAR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386077 DELTA CER HEAD 12/14 36MM +12 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 4130626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown