• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Injury (2348); Impaired Healing (2378); No Code Available (3191)
Event Date 04/17/2017
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, "clinical study of applying s-rom femoral prosthesis in hip joint revision" written by shang piao, yonggang zhou, yinqiao du, haiyang ma, jingyang sun, zhisen gao, yawen peng, and wenming wu published by china orthopaedic trauma, april 2017, volume 30, no 4 was reviewed for mdr reportability. The purpose of the study is to discuss the mid-term clinical efficacy of applying s-rom femoral prosthesis in hip joint revision for femoral reconstruction. The data was complied from 21 patients (21 hips) receiving hip joint revision between january 2008 and january 2016 with follow up range of 12-97 months. A number of patients received the following depuy products: pinnacle cup (8 patients), duraloc cup (2 patients) and reinforcement ring (4 patients); all patients received s-rom stem; bearing surfaces were cop (6 patients) and coc (15 patients). Others received non-depuy products indicating patients received a mixture of products within their revision surgeries. The article reveals 2 patients with identifiers with adverse events which are captured in linked complaints. Article does not provide adequate information to determine accurate quantity numbers of affected products. This complaint captures the adverse events without patient identifiers: 4 intra-operative proximal femoral fractures treated with wiring (1 patients), binding belt (2 patients), and cable ready plate (1 patient); non-union incision treated with local debridement; bone stress shielding without impact to function and no loosening (4 patients).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN HIP FEMORAL AUGMENT
Type of DeviceHIP FEMORAL AUGMENT
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 Key9187714
MDR Text Key173020442
Report Number1818910-2019-109040
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
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 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
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 Treatment Data
Date Received: 10/14/2019 Patient Sequence Number: 1
-
-