BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9267066 · Received November 1, 2019

    Report

    Report Number
    1818910-2019-111240
    Event Type
    Injury
    Date Received
    November 1, 2019
    Report Date
    October 11, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿A COMPARISON OF ACETABULAR IMPACTION GRAFTING AND TRABECULAR METAL FOR REVISION ARTHROPLASTY¿ BY FIACHRA E. ROWAN, ET AL, PUBLISHED BY HIP INTERNATIONAL (2016), VOL, 26, NO. 4, PP. 350-354, DOI: 10.5301/HIPINT.5000362, WAS REVIEWED. IN THIS RETROSPECTIVE COMPARATIVE CASE-CONTROL SERIES, THE AUTHORS COMPARE ACETABULAR IMPACTION BONE GRAFTING (AIBG) AND TRABECULAR METAL (TM) ACETABULAR RECONSTRUCTION FROM A SINGLE INSTITUTION OVER A 5- TO 10-YEAR PERIOD. THE AIM WAS TO DETERMINE ANY SIGNIFICANT DIFFERENCE IN RADIOLOGICAL OR CLINICAL OUTCOMES BETWEEN BOTH ACETABULAR SURGICAL REVISION STRATEGIES. THIS ARTICLE FOCUSES ON ACETABULAR RECONSTRUCTION DURING COMPETITOR CUP REVISION. IMPLANTED PRODUCTS: THE INITIAL IMPLANTS FOR THAS WERE A COMPETITOR CUP AND LINER WITH A CHARNELY FEMORAL COMPONENT. IF A CONCOMITANT FEMORAL REVISION WAS INDICATED, EITHER A DEPUY NONMODULAR SOLUTION STEM OR A DEPUY MODULAR RECLAIM SYSTEM WAS USED. THERE WERE 2 REVISIONS OF AN ASR HRA INCLUDED WITHIN THE STUDY, ASSIGNED TO THE IMPACTION BONE GRAFTING GROUP. THE REASONS FOR CUP REVISION INCLUDED ACETABULAR OSTEOLYSIS AND SEPSIS (4 CASES). THERE WAS ONE PERIPROSTHETIC FRACTURE FOR A CHARNLEY STEM THAT WAS REVISED. THE REMAINING REASONS FOR CHARNLEY STEM REVISION (33) WERE UNSPECIFIED INSTABILITY, FEMORAL OSTEOLYSIS, AND SEPSIS. THE FEMORAL OSTEOLYSIS IS ATTRIBUTED TO THE COMPETITOR POLYETHYLENE LINER. IMPLANTED PRODUCTS AT REVISION WERE A COMPETITOR CUP AND LINER AND A DEPUY STEM AND HEAD. REVISION RESULTS: THIS ARTICLE DISCUSSES THE OUTCOMES OF REVISION FOR COMPETITOR CUPS AND LINERS AND WILL THEREFORE NOT BE INCLUDED IN THIS COMPLAINT. OF THE STEMS AND HEADS REVISED, 1 NEEDED RESECTION ARTHROPLASTY FOR SEPSIS AND ANOTHER WAS REVISED AT ANOTHER INSTITUTION FOR UNKNOWN REASONS. CAPTURED IN THIS COMPLAINT: 1 ASR HEMIARTHROPLASTY FOR OSTEOLYSIS AND SEPSIS. 33 CHARNLEY STEMS FOR SEPSIS, AND UNSPECIFIED INSTABILITY. THE AUTHORS DO NOT ATTRIBUTE THE JOINT INSTABILITY TO A SPECIFIC PRODUCT OR LOCATION. THE OSTEOLYSIS LISTEN IN THE ARTICLE IS ATTRIBUTED TO THE COMPETITOR POLYETHYLENE LINER. 33 DEPUY FEMORAL HEADS FOR SEPSIS, AND UNSPECIFIED INSTABILITY. THE AUTHORS DO NOT ATTRIBUTE THE JOINT INSTABILITY TO A SPECIFIC PRODUCT DEFECT OR LOCATION. THE OSTEOLYSIS LISTEN IN THE ARTICLE IS ATTRIBUTED TO THE COMPETITOR POLYETHYLENE LINER. 1 FEMORAL STEM, HEAD, AND SLEEVE RE-REVISED FOR SEPSIS. 1 FEMORAL STEM, HEAD, AND SLEEVE RE-REVISED FOR UNKNOWN CAUSES. THE AUTHORS PROVIDE INFORMATION ON PAGE 353 IN FIG, 1 REGARDING AND ASR HEMIARTHROPLASTY REVISED FOR SEPSIS. THIS COMPLAINT IS LABELED CASE 1 IN THE GUIDANCE DOCUMENT. PLEASE LINK THAT COMPLAINT TO PARENT (B)(4)." ASR HEMI ARTHROPLAST REVISED 3 YEARS FOLLOWING INDEX THA FOR SEPSIS AND ACETABULAR OSTEOLYSIS. IMPLANTED WITH A DEPUY STEM AND HEAD AND COMPETITOR ACETABULAR COMPONENTS DURING ACETABULAR RECONSTRUCTION USING IMPACTION BONE GRAFTING. THE ACETABULAR RECONSTRUCTION FAILED AND REQUIRED A RE-REVISION OF THOSE COMPONENTS. NO DEPUY PRODUCTS CONTRIBUTED TO THE RE-REVISION FAILURE AND ARE THEREFORE NOT CAPTURED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063967 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention