• 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 ACETABULAR CUP

  • 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 ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Heart Failure (2206)
Event Date 09/03/2008
Event Type  Death  
Manufacturer Narrative
Product complaint # (b)(4). Report source is a literature article. There is limited information regarding the reported death. 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, "penetration of a metallic femoral head through the acetabular shell" written by robert a. Sherman, md, and timothy a. Damron, md published by the journal of arthroplasty vol. 24 no. 7 2009 accepted by publisher 3 september 2008 was reviewed. The article purpose was to report on one case of an (b)(6) year old man who underwent l tha implanted with depuy profile stem and acetabular cup system. Medical history includes coronary artery disease, hypertension, osteoarthritis, dysrhythmia and trigeminal neuralgias. Eighteen years post implantation he presented painful hip rom and a shortened, externally rotated left lower extremity. Radiographs revealed the appearance of a traditional dislocation but the head/neck was noted to be overlying the acetabular component on both anteroposterior and lateral views so no attempts at closed reduction. Revision operation was performed and intraoperative findings included metallosis, eroded poly liner and eroded metal shell, osteolysis with supra-acetabular bone surrounded by blackened metal debris. All components including stem were removed and replaced. Cancellous allograft utilized in acetabulum and allograft struts utilized in femur in conjunction with cable plate and wiring. It was estimated a 1300 ml blood loss. Patient was placed in icu and within 12 hours his medical condition worsened necessitating re-intubation and immediately followed by catastrophic cardiac injury and died. Depuy products utilized: profile stem, metal head, metal cup, poly liner. Adverse events: death, cardiac failure, dislocation, revision, foreign body reaction (stemming from liner, cup and head as the liner was worn and cup and head resulted in metal debris with note of implant erosion), major bleed, pain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
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, IN 46581-0988
6103142063
MDR Report Key9427082
MDR Text Key169552091
Report Number1818910-2019-121583
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
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 Received01/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2019 Patient Sequence Number: 1
-
-