BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +5 12/14

    MDR report key: 24308201 · Received February 10, 2026

    Report

    Report Number
    1818910-2026-02781
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 26, 2026
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    UDI-DI
    10603295359159
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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 (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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿EVENT DESCRIPTION¿ HCP REPORTED ABOUT A PATIENT WHO HEARD A LOUD CRACKING SOUND UPON GETTING UP FROM THE TOILET. SUBSEQUENT X-RAY EXAMINATION REVEALED A FRACTURE OF THE FEMORAL HEAD IMPLANT. PRODUCT DESCRIPTION: HIP BALL BIOLOX 32 +5 12/14. PRODUCT CODE: 9111132. LOT NO: 9615172. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 10/15/2020. EXPIRY DATE: 09/30/2025. IFU REFERENCE: IFU-0902-00-701. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: HIP BALL BIOLOX 32 +5 12/14 PRODUCT CODE: 9111132; LOT NO: 9615172, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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 ANY PREEXISTING MATERIAL DEFECT. 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. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 10/15/2020. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 09/30/2025. 5) IFU REFERENCE: IFU-0902-00-701. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: HIP BALL BIOLOX 32 +5 12/14 PRODUCT CODE: 9111132 ; LOT NO: 9615172 , AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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 ANY PREEXISTING MATERIAL DEFECT. ADDED: B5, D6A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HEARD A LOUD CRACKING SOUND UPON GETTING UP FROM THE TOILET. SUBSEQUENT X-RAY EXAMINATION REVEALED A FRACTURE OF THE FEMORAL HEAD IMPLANT. REVISION TOOK PLACE ON (B)(6) 2026.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE NEGATIVE CONSEQUENCE WAS THE NEED FOR FURTHER SURGERY, WITH THE ASSOCIATED RISKS, PAIN, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588627 HIP BALL BIOLOX 32 +5 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY IRELAND - 9616671 9615172 10603295359159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention