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 Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 06/06/2016

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, ""usefulness of prosthesis made of antibiotic-loaded acrylic cement as an alternative implant in older patients with medical problems and periprosthetic hip infections: a 2- to 10-year follow-up study"" written by woo-yong lee, md, deuk-soo hwang, md, phd, chan kang, md, phd, byung-kon shin, md, and long zheng, md published by the journal of arthroplasty (2016) 1-16 accepted by publisher 6 june 2016 was reviewed.The article's purpose: ""the purpose of this study was to compare the clinical outcomes after 2-stage revision with those following single-stage revision in patients who developed periprosthetic joint infection after primary hip arthroplasty."" data was compiled from 39 patients total (20 in group a treated with 2 stage revision using prostalac as interim prosthesis and 19 in group b treated with single-stage revising using prostalac as an alternative implant because of older age and/or medical problems.The article identifies two patients in radiographic images that received depuy product implants in their initial thas that required revision that are in this study.Each patient is captured individually in linked complaints" this complaint captures a (b)(6) female with a summit stem and self-centering bipolar head with ceramic head at initial r tha.The patient complained of right hip pain, swelling a sense of hotness.She was diagnosed with an enteroccus infection and received a 1 stage treatment with prostalac as an alternative implant.

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.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9281906
• MDR Text Key: 178150808
• Report Number: 1818910-2019-111689
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/08/2020
• 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
• Patient Age: 86 YR