BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CONSTRUCT ASR

    MDR report key: 20855396 · Received December 5, 2024

    Report

    Report Number
    1818910-2024-24925
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    July 11, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: B3: EXACT DATE OF EVENT IS UNKNOWN; JULY 11, 2024, IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. 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 :THERE IS NO EVIDENCE SUGGESTING MANUFACTURING OR MATERIAL ERROR AS A POTENTIAL CAUSE FOR THE INCIDENT INVOLVING THE ASR PLATFORM. WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MIN M, XING C, XU P, WEI X, FAN L. CASE REPORT: FORMATION AND RECURRENCE OF INFLAMMATORY PSEUDOTUMOR AFTER METAL-ON-METAL HIP ARTHROPLASTY. FRONT MED (LAUSANNE). 2024 JUL 11; 11:1422230. DOI:10.3389/FMED.2024.1422230. PMID: 39055697; PMCID: PMC11269118. OBJECTIVE/METHODS/STUDY DATA: THE PRESENTED CASE WAS A 64-YEAR-OLD MALE PATIENT WAS HOSPITALIZED COMPLAINING OF RECURRENT RIGHT GROIN SWELLING AND RIGHT HIP PAIN WITH MOVEMENT FOR 6MONTHS. HE HAD A HISTORY OF HYPERTENSION AND CORONARY ARTERY DISEASE. THE PATIENT UNDERWENT A RIGHT MOM TOTAL HIP ARTHROPLASTY (ASR XL ACETABULAR SYSTEM, JOHNSON & JOHNSON MEDICAL LTD., SHANGHAI, CHINA) IN OUR HOSPITAL IN 2010 FOR RIGHT FEMORAL HEAD NECROSIS, A LEFT COP TOTAL HIP ARTHROPLASTY (CORAIL TOTAL HIP SYSTEM, JOHNSON & JOHNSON MEDICAL LTD., SHANGHAI, CHINA) IN OUR HOSPITAL IN 2017 FOR A TRAUMATIC LEFT FEMORAL NECK FRACTURE, AND RESECTION OF A LARGE PERIPROSTHETIC MASS IN 2019. THE PSEUDOTUMOR RECURRED AT THE SAME SITE AND HE UNDERWENT REVISION SURGERY (CORAIL REVISION HIP SYSTEM, JOHNSON & JOHNSON MEDICAL LTD., SHANGHAI, CHINA) IN 2021. AS OF 2024, THE PSEUDOTUMOR HAD NOT RECURRED AT THE 3-YEAR FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ASR XL ACETABULAR SYSTEM AND CORAIL TOTAL HIP SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT ASR (QTY.1) A 64-YEAR-OLD MALE PATIENT: EXPERIENCED PAIN, AND THE TREATMENT WAS REVISION SURGERY. LIMITED RANGE OF MOTION, AND THE TREATMENT WAS REVISION SURGERY. A GRAYISH-BLACK SILT-LIKE MATERIAL AND NECROTIC CONNECTIVE TISSUE WERE SIGNIFICANTLY OBSERVED AROUND THE PROSTHESIS. TREATMENT WAS REVISION SURGERY. A PERIPROSTHETIC, INFLAMMATORY PSEUDOTUMOR WAS NOTED AFTER RIGHT HIP ARTHROPLASTY. TREATMENT WAS REVISION SURGERY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY.1) A 64-YEAR-OLD MALE PATIENT: EXPERIENCED PAIN, AND THE TREATMENT WAS REVISION SURGERY. LIMITED RANGE OF MOTION, AND THE TREATMENT WAS REVISION SURGERY. A GRAYISH-BLACK SILT-LIKE MATERIAL AND NECROTIC CONNECTIVE TISSUE WERE SIGNIFICANTLY OBSERVED AROUND THE PROSTHESIS. TREATMENT WAS REVISION SURGERY. A PERIPROSTHETIC, INFLAMMATORY PSEUDOTUMOR WAS NOTED AFTER RIGHT HIP ARTHROPLASTY. TREATMENT WAS REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095587 UNKNOWN HIP ACETABULAR CONSTRUCT ASR JRN : HIP ACETABULAR LINERS LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention