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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/17/2016

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Report source is from a literature article.The information regarding the reported dealth is very limited.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "feasibility and safety of 2-day discharge after fast-track total hip arthroplasty: a chinese experience" written by guojing yang, md, wanchen chen, md, wenliang chen, md, xiaojun tang, md, yijiang huang, md, and lei zhang, md published by the journal of arthroplasty 31 (2016) 1686e1692 http://dx.Doi.Org/10.1016/j.Arth.2016.02.011 on 17 february 2016 was reviewed for mdr reportability.The purpose: "the primary purpose of this prospective randomized study was to investigate the feasibility and safety of early discharge after fast-track tha in a chinese population." data was compiled from 126 patients in the fast track (ft) group and 132 patients in the standard program (st) group receiving tha between november 2013 and april 2014 with a follow up of 3 months.Complications at 30 month are included in adverse events as well.Patients received depuy pinnacle cups and either corail or summit stems.Bearing surfaces are not specified but it is reasonable to conclude the femoral head and liner were depuy products.The article does not provide adequate information to determine exact quantities of products as patients may experience more than one adverse events.The article does not provide information regarding interventions for adverse events.Adverse events: stroke, cardiac infarction, dvt, pulmonary embolism, infection, fracture (unspecified), death (1 accounted for in the st group), nausea, vomiting, dizziness, cognitive dysfunction, stroke, dislocation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.Additional narrative: product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9210105
• MDR Text Key: 162900456
• Report Number: 1818910-2019-108968
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death