MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Weakness (2145); No Code Available (3191)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, "diagnosis and management of adverse local tissue reactions secondary to corrosion at the head-neck junction in patients with metal on polyethylene bearings" written by darren r.Plummer, md, mba, richard a.Berger, md, wayne g.Paprosky, md, scott m.Sporer, md, joshua j.Jacobs, md, and craig j.Della valle, md published by the journal of arthroplasty http://dx.Doi.Org/10.1016/j.Arth.2015.07.039 on 27 july 2015.The article's purpose: "to describe our experience with the diagnosis and treatment of patients with a metal-on polyethylene (mop) bearing, who presented with symptomatic altrs secondary to corrosion at the modular head-neck junction." the article reports out of 27 cases depuy stems were utilized in 3 cases and 2 of them had depuy acetabular components but the other was utilized with a non depuy acetabular component.The article does not identify which adverse events are associated with depuy products: pain, swelling, muscles weakness, limp, altr, revisions, recurrence of altr, re-revision, periprosthetic joint infection (successfully treated with a two-stage exchange, recurrent instability treated with revision to constrained liner, and peroneal nerve palsy that self resolved.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions 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.H10 additional 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 number 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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9129040
• MDR Text Key: 164404649
• Report Number: 1818910-2019-106507
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention