Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS STRYKER REJVUENATE MODULAR IMPLANT; MODULAR HIP IMPLANT NECK
  • 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
 

STRYKER ORTHOPAEDICS STRYKER REJVUENATE MODULAR IMPLANT; MODULAR HIP IMPLANT NECK Back to Search Results
Lot Number 31987301
Device Problem Metal Shedding Debris (1804)
Patient Problems Toxicity (2333); Fluid Discharge (2686); Test Result (2695); No Code Available (3191)
Event Date 11/12/2010
Event Type  Injury  
Event Description
On (b)(6) 2010, this (b)(6) year old male underwent a total right hip arthroplasty under doctor (b)(6).A stryker rejuvenate modular stem and neck device was implanted.The pt became symptomatic with his hip and went to see doctor (b)(6).He had needle aspiration done on (b)(6) 2013.On (b)(6) 2014, pt underwent revision of the right hip and had the stryker rejuvenate device explanted by doctor (b)(6).Extensive debridement of the joint was done.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRYKER REJVUENATE MODULAR IMPLANT
Type of Device
MODULAR HIP IMPLANT NECK
Manufacturer (Section D)
STRYKER ORTHOPAEDICS
325 corproate drive
mahwah NJ 07430
MDR Report Key3621938
MDR Text Key4133608
Report Number3621938
Device Sequence Number1
Product Code MEH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/29/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2015
Device Lot Number31987301
Other Device ID NumberNLS-340000B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2014
Distributor Facility Aware Date01/17/2014
Device Age38 MO
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
Patient Weight89
-
-