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

Model Number 36378801

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/08/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, this (b)(6) y/o female underwent a total right hip arthroplasty under dr.(b)(6).A stryker rejuvenate modular neck and stem device was implanted.Pt became symptomatic with her lip and went to see (b)(6).She had hip aspiration done on (b)(6) 2014.Pt underwent revision of right hip and had stryker rejuvenate device explanted by dr.(b)(6).Extensive debridement of the joint was done.

• Brand Name: STRYKER REJUVENATE MODULAR NECK
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS; 325 corporate drive; mawah NJ 07430
• MDR Report Key: 4361027
• MDR Text Key: 5286646
• Report Number: 4361027
• Device Sequence Number: 1
• Product Code: MEH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2014
• 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 Date: 04/01/2016
• Device Model Number: 36378801
• Device Lot Number: 36378801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Device Age: 41 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 89