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 Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Respiratory Failure (2484)

Event Date 08/21/2008

Event Type  Death  

Manufacturer Narrative

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

Event Description

"literature article entitled, ¿cemented versus uncemented hemiarthroplasty for displaced femoral neck fractures¿ by wender figved md, et al, published by clinical orthopaedic related research (2009), vol.467, pp.2426-2435, was reviewed.The purpose of this article is to compare the results of cemented versus uncemented hemiarthroplasties implanted into the frail elderly after a displaced femoral neck fracture.This complaint will capture the initial study results as well as the results of the 5 year follow up.Implanted depuy products: all patient received a depuy bipolar head (mobile bipolar head and cocr modular head).The cemented group was implanted with a competitor stem secured with competitor cement.The cementless group was implanted with a corail femoral stem.Results: the authors provide a detailed list of patients and postoperative outcomes.These cases are detailed within the guidance document labeled case 1-case 16.This parent complaint will capture the deaths noted in the study and the additional results provided within the 5 year follow up.There were 4 deaths that occurred within 72 hours of the index operation.One patient experienced a severe decrease in blood pressure during the cementing procedure and died within 24 hours owing to an acute myocardial infarction.This death is attributed to the competitor cement and will not be included in this complaint.Another patient in the cemented group experienced cardiac arrest during wound closure and died of a myocardial infarction within 72 hours.The only depuy product used in this procedure was the depuy bipolar head- the stem and the cement were competitor products.2 patients died of respiratory failure within 72 hours of index surgery.In the five-year follow-up, the authors note there were 3 additional periprosthetic femoral fractures treated with internal fixation.Captured in (b)(4): mobile bipolar head, cocr modular head, and corail stem: death.Corail stem: no reported product problem.Patient harms: myocardial infarction, cardiac arrest, respiratory failure, fracture post op, surgical intervention.The corail stem will not be coded for cardiac arrest and myocardial infarction because this implant was not used in the cemented procedure.Case 1 through case 16 are linked to (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional information: patient code (1762) cardiac arrest.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.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 complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Post market surveillance is per sep 419.Device history lot null.Device history batch null.Device history review null.

• 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: 9380404
• MDR Text Key: 168175151
• Report Number: 1818910-2019-118234
• Device Sequence Number: 1
• Product Code: KXA
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death