MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

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

Patient Problem Death (1802)

Event Date 01/01/2002

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Report source is a literature article.There is very limited information regarding the reported death.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, "prevalence of fat embolism following bilateral simultaneous and unilateral total hip arthroplasty performed with or without cement" written by young-hoo kim, md, s.W.Oh, md, and j.S., md published by the journal of bone and joint surgery 2002 was reviewed.The article's purpose: "the purpose of the present study was to determine if unilateral and bilateral simultaneous total hip arthroplasty procedures resulted in different prevalences of fat embolization, different degrees of hemodynamic compromise, or different levels of hypoxemia or mental status changes." the data was compiled from 106 patients undergoing unilateral tha between march 1997 and may 1999.Depuy products utilized: duraloc cup (all hips), cementless profile and cemented elite plus femoral on contralateral side for bilateral tha group, in the unilateral surgeons alternated between cementless profile and cemented elite stems, cement restrictor with elite stems (cement was non-depuy).Results were no differences in fat embolism between the two groups.Adverse events: diffuse encephalopathy with confusion and agitation that lasted about 24 hours (2 in each group of unilateral and bilateral), 1 death 7 days post implantation with no clear cause (in unilateral group), dvt (both groups).

Manufacturer Narrative

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.Corrected: h6.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.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.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9249665
• MDR Text Key: 164094437
• Report Number: 1818910-2019-112792
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death