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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 01/20/2012

Event Type  malfunction  

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, "large-diameter modular metal-on-metal total hip arthroplasty" written by william p.Barrett, md, kirk a.Kindsfater, md, and james p.Lesko published by the journal of arthroplasty vol.27 no.6 2012 accepted by publisher 20 january 2012 was reviewed.The article's purpose is to present the results of 4 clinical trials with modular mom bearing total hip system with special focus on the small subset of revisions attributed to an armed (adverse reaction to metallic debris).The data was compiled from 4 studies of 779 thas and pulled 22 revision cases.All cases had depuy products and each case is captured individually in linked complaints.Depuy products: stem (various and identified individually), pinnacle cup, ultamet metal liner, metal femoral head this complaint captures case #1 (b)(6) year old male with summit stem and received revision 2.9 years post initial implantation for pain and positive findings of armed.Narrative description provides further detail of findings of corrosion on both the head and stem of the head/stem junction but head and liner were only exchanged to mop bearings.His frozen section revealed necrotic tissue and fibrous tissue consistent with a pseudotumor-type reaction.No infection.

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.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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9412488
• MDR Text Key: 217439500
• Report Number: 1818910-2019-120308
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1