BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +1 12/14

    MDR report key: 17539622 · Received August 14, 2023

    Report

    Report Number
    1818910-2023-16633
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 14, 2023
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: HCP IS REPORTING TO NCA/BFARM: "HIP-TEP REVISION (STEM PLUS HEAD AND INSERT CHANGE) LEFT SIDE ON (B)(6) 2023 AFTER FRACTURE OF THE CERAMIC HEAD LEFT SIDE (BICYCLE CRASH TO THE LEFT HIP). STEM CHANGE DUE TO TAPER DESTRUCTION BY THE CERAMIC PARTICLES (PICTURES ARE AVAILABLE AND CAN BE REQUESTED). ON (B)(6) 2015: PRIMARY HIP-TEP LEFT SIDE IN OUR HOSPITAL. REF: 101214050, LOT: 600428 TRILOCK BPS STEM, HO, GR 5, L105 MM, DEPUY. REF: 9111131, LOT: 8061698 BIOLOX CERAMIC HIP HEAD D 32+1.0MM 12/14 NECK LENGTH SHORT, DEPUY. REF: 0100013413 LOT 2780994 ALPHA INSERT DURASUL 32/MM, ZIMMER. REF: 4249, LOT: 2784417 ALLOFIT CUP 60/MM, TITANIUM ALLOCLASIC, ZIMMER. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE HIP BALL BIOLOX 32 +1 12/14 HAS BROKEN INTO MULTIPLE FRAGMENTS, FOUR LARGE PIECES CAN BE OBSERVED ON THE PROVIDED EVIDENCE. NO OTHER DEFECTS WERE OBSERVED ON THE PROVIDED EVIDENCE. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT, HOWEVER IN SUPPORT OF THE EVALUATION PERFORMED, THE OBSERVED DAMAGE OF THE HIP BALL BIOLOX 32 +1 12/14 MAY HAVE BEEN CAUSED BY THE REPORTED PATIENT'S BICYCLE ACCIDENT AND/OR MIXING OF MANUFACTURERS ON THE SAME SYSTEM OF HIP REPLACEMENT. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [9111131 / 8061698] 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 ANY PRE-EXISTING MATERIAL DEFECT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HIP BALL BIOLOX 32 +1 12/14 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 ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE FEMORAL HEAD CONFIRMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. 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 PRE-EXISTING MATERIAL DEFECT. 1) QUANTITY MANUFACTURED: (B)(4), 2) DATE OF MANUFACTURE: 2015-01-30, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE, 4) EXPIRY DATE: 2019-12-31, 5) IFU REFERENCE: IFU-0902-00-701. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [9111131 / 8061698] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES 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

    HIP-TEP REVISION (STEM PLUS HEAD AND INSERT CHANGE) AFTER FRACTURE OF THE CERAMIC HEAD (BICYCLE CRASH TO THE LEFT HIP). STEM CHANGE DUE TO TAPER DESTRUCTION BY THE CERAMIC PARTICLES. DOI: (B)(6) 2015. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084100 HIP BALL BIOLOX 32 +1 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY INTERNATIONAL LTD - 8010379 8061698

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention TRI-LOCK BPS SZ 5 HI OFFSET.| UNKNOWN HIP ACETABULAR LINERS.