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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); No Code Available (3191)

Event Date 01/01/2005

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, "high failure rate of a constrained acetabular liner in revision total hip arthroplasty" written by craig j.Della valle, md, dennis chang, md, scott sporer, md, richard a.Berger, md, aaron g.Rosenberg, md and wayne g.Paprosky, md published by the journal of arthroplasty vo.20 no.7 suppl.3 2005 was reviewed.The article's purpose is to report the experience of utilizing a duraloc constrained liner in a consecutive series of revision thas.Data was compiled from 51 patients and 55 tha revisions with age range 26-87 years.Of the 55 revisions, 52 had cementless cups of either duraloc or solution, 2 had non depuy cups and 1 had a depuy protrusio cage.Although the article does not identify the femoral components, it is assumed that complimentary depuy femoral components were utilized.The article does not identify specific products or product platforms associated with adverse events.Depuy products: duraloc or solution cups, constrained poly liner, head, stem, protrusio cage adverse events: disassociation of constraining ring leading to dislocation noted that liner stayed intact within cup (treated by revision - with or without head/liner exchange or closed reduction) - see figure 1 radiographic image hematoma (treated by surgical evacuation) infection (treated by irrigation and debridement with retention of the components.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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 FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9629123
• MDR Text Key: 178373670
• Report Number: 1818910-2020-02909
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention