MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.

Event Description

"literature article entitled, ¿femoral revision surgery using a fully hydroxyapatite-coated stem: a cohort study of twenty two to twenty seven years¿ by olav reikeras, published by international orthopaedics (2017), vol.41, pp.271-275, was reviewed.The purpose of this study was to evaluate the long-term outcome using an extensively hydroxyapatite (ha)-coated corail (depuy) stem in femoral revisions surgery performed in 66 hips between 1988-1993.During the revision surgeries, 40 cups were also revised.The acetabular components used in both the index and revision surgeries are unknown and not included in this complaint.Implanted depuy products: corail stem and biolox ceramic femoral heads.Results: 2 periprosthetic femoral fractures- treatment unknown.1 stem revision for deep infection.1 proximal intraoperative femoral perforation during insertion of the stem stabilized with cerclage.The stem never stabilized and subsided causing pain and stem migration.The stem was revised at 1 year.2 instances of subsidence greater than 5-mm.1 instance of stem loosening treated with surgical cerclage stabilization in the subsided position.20 radiologically identified cases of bone hypertrophy confirmed in serial follow-up radiographic studies-treatment undefined.5 cases of femoral osteolysis identified and confirmed in progressive radiographic studies-treatment unspecified.Captured in this complaint: corail femoral stem: implant migration, implant loosening; biolox femoral head: no reported product problem.Patient harms: pain, infection, inadequate osseointegration, surgical intervention, medical device removal, bone injury, medical device site erosion.There is insufficient information to attribute the osteolysis, associated with polyethylene wear, to the femoral head or femoral stem.The intraoperative femoral perforation is coded for bone injury.".

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9385079
• MDR Text Key: 195720934
• Report Number: 1818910-2019-118481
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1