BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 19627501 · Received June 27, 2024

    Report

    Report Number
    1818910-2024-14155
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 19, 2024
    Report Date
    June 27, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    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 : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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 : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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 : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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

    ADDITIONAL INFORMATION RECEIVED: A. REF AND PLUMB BOB OF ALL COMPONENTS USED DURING (INITIAL) IMPLANTATION. COVER SCREW, FOR DURALOC/PINNACLE CUPS, APEX HOLE CLOSURE REF (B)(4). LOT D23080763 ACETABULAR CUP, D48MM, SECTOR, PINNACLE REF (B)(4). LOT M25P05 SCREW, D6.5MM, L30MM, LOW PROFILE, PINNACLE REF (B)(4). LOT D22031894 SCREW, D6.5MM, L25MM, LOW PROFILE, PINNACLE REF (B)(4). LOT D22020889 SCREW, D6.5MM, L20MM, LOW PROFILE, PINNACLE REF (B)(4). LOT D21041571 HIP INLAY, AD48MM, ID32MM, +4 MARATHON, SPIROFIT, PINNACLE REF (B)(4). LOT M3446W HIP STEM, SIZE 10, 140MM, STD, CORAIL AMT REF (B)(4). LOT 5528587 FEMORAL HEAD, AD32MM, NECK LENGTH + 1MM, TAPER 12/14, BIOLOX DELTA, CERAMAX REF (B)(4). LOT 4232781 B. REASON FOR THE REVISION: RECURRENT H-TEP DISLOCATION ON THE RIGHT. FIRST REVISION ON 15.1.2024 WITH CHANGE TO A DYSPLASIA INLAY AND A MERETE CERAMIC HEAD 32 MM WITH HEAD CONE ADAPTER 2 XL 7.5 DEGREES. C. DID A SURGERY TIME EXTENSION OCCUR DURING THE REVISION? IF YES, HOW LONG? THERE WAS NO EXTENSION OF THE SURGERY TIME. D. SIDE AFFECTED? RIGHT SIDE.

    Description of Event or Problem · 0

    REVISION OF ACETABULAR COMPONENTS OF A HIP-TEP. A PINNACLE CUP WAS CHANGED TO A BI-MENTUM CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192029 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention APEX HOLE ELIM POSITIVE STOP| PINN CAN BONE SCREW 6.5MMX20MM| PINN CAN BONE SCREW 6.5MMX25MM| PINN CAN BONE SCREW 6.5MMX30MM| UNK HIP ACETABULAR CUP PINNACLE| UNK HIP FEMORAL HEAD CERAMIC