BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 13979529 · Received April 1, 2022

    Report

    Report Number
    1818910-2022-05992
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 20, 2021
    Report Date
    April 1, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT :A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED ABDEL MP, WYLES CC, VISTE A, PERRY KI, TROUSDALE RT, BERRY DJ. EXTENDED TROCHANTERIC OSTEOTOMY IN REVISION TOTAL HIP ARTHROPLASTY: CONTEMPORARY OUTCOMES OF 612 HIPS. J BONE JOINT SURG AM. 2021 JAN 20;103(2):162-173. DOI: 10.2106/JBJS.20.00215. PMID: 33252587. OBJECTIVE AND METHODS: THE GOALS OF THE CURRENT STUDY WERE TO ASSESS THE UNION RATE, COMPLICATIONS, AND OUTCOMES OF CONTEMPORARY EXTENDED TROCHANTERIC OSTEOTOMIES (ETOS) PERFORMED DURING REVISION THAS AT A SINGLE INSTITUTION BETWEEN 2003-2013. A RETROSPECTIVE REVIEW OF 612 ETOS PERFORMED DURING REVISION OF UNKNOWN DEVICES WERE INCLUDED IN THE STUDY. THE REVISED DEVICES, AS WELL AS THE NEWLY IMPLANTED ACETABULAR COMPONENTS ARE UNKNOWN. THE STUDY INDICATES THAT 265 COMPETITOR SEGMENTED STEMS, 134 COMPETITOR MODULAR RESTORATION STEMS, 69 UNCEMENTED UNKNOWN STEMS, AND 144 DEPUY SOLUTION STEMS WERE UTILIZED IN THE RECONSTRUCTION. THE MANUFACTURER OF THE FEMORAL HEADS WAS NOT SPECIFIED. THE MANUFACTURER OF THE CABLES UTILIZED TO SECURE THE REVISION STEM ARE UNKNOWN. THE AUTHORS CONCLUDED THE USE OF ETOS SHOWS THAT THE UNION RATE IS HIGH AND CLINICALLY IMPORTANT TROCHANTERIC MIGRATION IS INFREQUENT. THE MOST COMMON COMPLICATIONS ARE FRACTURE OF THE OSTEOTOMY FRAGMENT INTRAOPERATIVELY OR POSTOPERATIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SOLUTIONS FEMORAL STEM, SOLUTIONS FEMORAL BROACH, SOLUTIONS FEMORAL STEM TRIAL, SOLUTIONS FEMORAL REAMER, UNKNOWN FEMORAL HEAD. THIS COMPLAINT WILL CAPTURE ALL EVENTS POTENTIALLY ASSOCIATED WITH THE DEPUY DEVICES. RESULTS ASSOCIATED WITH THE COMPETITOR IMPLANTS WILL BE EXCLUDED. THE FEMORAL HEADS UTILIZED WITH THE STEMS ARE UNKNOWN. IT IS REASONABLE TO ASSUME THAT A DEPUY FEMORAL HEAD WAS PAIRED WITH THE DEPUY SOLUTIONS STEM, THOUGH THIS IS NOT CONFIRMED. THE ACETABULAR COMPONENTS UTILIZED IN THIS STUDY ARE UNKNOWN. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY DEVICES: AS THERE IS INSUFFICIENT INFORMATION PROVIDED TO CAPTURE THE ACTUAL DEVICES REVISED, THIS COMPLAINT WILL CAPTURE ALL OF THE FOLLOWING EVENTS WITH THE QUANTITY OF 1. REVISIONS: ASEPTIC LOOSENING OF THE STEM, STEM FRACTURE, PERIPROSTHETIC JOINT INFECTION (STEM AND HEAD), LEG LENGTH DISCREPANCY (STEM AND HEAD), DISLOCATION (HEAD). INTRAOPERATIVE FEMORAL FRACTURES TREATED WITH CABLING: FEMORAL FRACTURE WHILE TRIALING/REDUCING THE FEMORAL STEM, FEMORAL FRACTURE WHILE REAMING THE FEMUR, FEMORAL FRACTURE WHILE BROACHING, FEMORAL FRACTURE DURING STEM IMPLANTATION. REOPERATIONS: UNSPECIFIED SURGICAL PROCEDURE TO ADDRESS NON-UNION OF AN OSTEOTOMY SITE, IRRIGATION AND DEBRIDEMENT TO TREAT INFECTION, REMOVAL OF UNSPECIFIED HARDWARE. POST-OPERATIVE COMPLICATIONS: INFECTION- TREATMENT UNSPECIFIED, DISLOCATION: TREATMENT UNSPECIFIED, PERIPROSTHETIC FEMORAL FRACTURE: TREATMENT UNSPECIFIED. RADIOGRAPHIC FINDINGS: MIGRATION OF THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869385 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK BROACH| UNK FEMORAL TRIAL| UNK HIP FEMORAL STEM SOLUTION| UNK REAMER| UNKNOWN HIP FEMORAL HEAD