BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 32IDX50OD

    MDR report key: 16654668 · Received March 31, 2023

    Report

    Report Number
    1818910-2023-07015
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    May 19, 2022
    Report Date
    March 31, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016281
    PMA / PMN Number
    K072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 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. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. INITIAL REPORTER OCCUPATION: LAWYER. COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    THIS COMPLAINT WAS CREATED IN RELATION TO AEI NOTE A-8851225 UNDER (B)(4) STATED THAT (B)(4) MEDICAL RECORDS AD 1 MAR 2023 (2), (B)(4) MEDICAL RECORDS AD 1 MAR 2023 (3) WERE REVIEWED BY CLINICIAN. ON (B)(6) 2010, THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED AT THIS TIME. ON (B)(6) 2022, THE PATIENT HAD A RIGHT REVISION TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY. IT WAS NOTED THE PATIENT HAD PAIN, ELEVATED SERUM LEVELS OF COBALT AND CHROMIUM, AND RADIOGRAPHS SHOWED OSTEOLYSIS. DEPUY METAL ON METAL HEAD/LINER WERE REVISED TO A POLY ON CERAMIC CONSTRUCT. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. (B)(4). ON (B)(6) 2022, THE PATIENT HAD A RIGHT HIP REVISION TO ADDRESS RIGHT HIP CELLULITIS. THE POSTOPERATIVE DIAGNOSIS INCLUDED HEMATOMA AND FASCIA/GLUTEUS DEHISCENCE. THE PATIENT WAS EXPERIENCING SWELLING, PAIN AND SOME REDNESS. THE PATIENT WAS NOTED TO BE 6 WEEKS POSTOP FROM RIGHT REVISION TO CERAMIC ON POLY BEARING SURFACE. DOI: (B)(6) 2010 - CUP, STEM AND 2 BONE SCREWS. DOI: (B)(6) 2022-CERAMIC HEAD AND POLY LINER. DOR: (B)(6) 2022. RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059611 ALTRX +4 NEUT 32IDX50OD ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US JP0983 10603295016281

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention DLT TS CER HD 12/14 32MM +9| PINN CAN BONE SCREW 6.5MMX20MM| PINN CAN BONE SCREW 6.5MMX20MM| PINNACLE SECTOR II CUP 50MM| SUMMIT POR TAPER SZ4 STD OFF| UNK HIP ACETABULAR LINER POLY| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP FEMORAL HEAD CERAMIC| UNK HIP FEMORAL STEM SUMMIT| UNKNOWN HIP ACETABULAR CUP