BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +1

    MDR report key: 24080877 · Received January 15, 2026

    Report

    Report Number
    1818910-2026-00937
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    November 20, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033431
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED: "ON DAY * THE LINER AND HEAD OF THE PATIENT WAS REPLACED *. THE DOCTOR ASKED US TO SEND THE MATERIAL FOR ANALYSIS, AS HE WAS STRUCK BY THE WEAR AND TEAR OBSERVED IN SUCH A SHORT PERIOD OF TIME. I ATTACH IMAGES OF THE EXTRACTED, AS WELL AS THE CERTIFICATE OF THE INITIAL SURGERY (DATE OF PLACEMENT *)". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (SOURCE FILE - FW EXTERNAL RECLAMO DE CALIDAD). THE PHOTO INVESTIGATION REVEALED THE DEVICE WITH METAL TRANSFER ON THEIR CONVEX AREA AND SIGNS OF BEING IMPLANTED FOR A PERIOD OF TIME. NO SIGN OF DEFORMATIONS NOR OTHER ANOMALY WAS IDENTIFIED ON THE DEVICE SURFACE AND EVIDENCE PROVIDED. METAL TRANSFER IS AN INDICATIVE OF THE DEVICE COMING IN CONTACT WITH THE CUP AS A CONSEQUENCE OF THE LINER FRACTURE. IT IS IMPORTANT TO MENTION THAT THE METAL TRANSFER IS NOT CONSIDERED A DEVICE NON-CONFORMANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3934267 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AND AS-RECEIVED CONDITION COULD NOT BE ASSESSED, A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER HEAD 12/14 32MM +1 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 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3934267 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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

    PATIENT UNDERWENT REVISION SURGERY. THE LINER AND HEAD OF THE PATIENT WAS REPLACED. THE DOCTOR WAS STRUCK BY THE WEAR AND TEAR OBSERVED IN SUCH A SHORT PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146805 DELTA CER HEAD 12/14 32MM +1 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 3934267 10603295033431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention APEX HOLE ELIM POSITIVE STOP.| PINN CAN BONE SCREW 6.5MMX30MM.| PINNACLE SECTOR II CUP 52MM.| UNKNOWN HIP ACETABULAR LINERS.| UNKNOWN HIP FEMORAL STEM.