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 REJUVENATE HIP IMPLANT
  • 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 REJUVENATE HIP IMPLANT Back to Search Results
Lot Number 29589301
Device Problem Fracture (1260)
Patient Problems Fall (1848); Toxicity (2333); Hip Fracture (2349)
Event Date 07/02/2010
Event Type  Injury  
Event Description
(b)(6) 2010, this (b)(6) yr old male underwent a total right hip arthroplasty under dr (b)(6).A stryker rejuvenate modular stem and neck device was implanted.This pt had been particularly symptomatic with his hip.However, on (b)(6) 2014, he fell and sustained a periprosthetic subtrochanteric right hip fracture.He was admitted to the emergency dept.Consult from dr (b)(6), ortho was obtained.He was ultimately admitted to bsa inpatient and dr (b)(6) explanted the recalled device the following day (b)(6) 2014, and performed orif.His post op dx was "periprosthetic fx status post right total hip replacement and adverse local tissue rxn causing osteomalacia and likely contributing to the fx secondary to cobalt toxicity and a stryker rejuvenate total hip.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRYKER REJUVENATE HIP IMPLANT
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS
325 corporate dr
mawah NJ 07430
MDR Report Key4321097
MDR Text Key5136058
Report Number4321097
Device Sequence Number1
Product Code JDI
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 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2014
Device Lot Number29589301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/20/2014
Distributor Facility Aware Date11/16/2014
Device Age4 YR
Event Location Ambulatory Surgical Facility
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age91 YR
Patient Weight83
-
-