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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS STRYKER REJVENATE MODULAR IMPLANT; MODULAR HIP IMPLANT NECK
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STRYKER ORTHOPAEDICS STRYKER REJVENATE MODULAR IMPLANT; MODULAR HIP IMPLANT NECK Back to Search Results
Lot Number 29589702
Device Problem Metal Shedding Debris (1804)
Patient Problems Toxicity (2333); Fluid Discharge (2686); Test Result (2695)
Event Date 10/20/2010
Event Type  Injury  
Event Description
On (b)(6) 2010, this male underwent a total left 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.On (b)(6) 2013, left hip aspiration was done and sent to pathology.On (b)(6) 2014, pt underwent revision of the left hip and had the stryker rejuvenate deice explanted by doctor (b)(6).Extensive debridement of the joint was done.
 
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Brand Name
STRYKER REJVENATE MODULAR IMPLANT
Type of Device
MODULAR HIP IMPLANT NECK
Manufacturer (Section D)
STRYKER ORTHOPAEDICS
325 corproate drive
mawah NJ 07430
MDR Report Key3621949
MDR Text Key4133601
Report Number3621949
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2014
Device Lot Number29589702
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 Date01/27/2014
Device Age39 MO
Event Location Ambulatory Surgical Facility
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/31/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age67 YR
Patient Weight125
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