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

Catalog Number NLV-340800Y

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Swelling (2091); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 05/09/2011

Event Type  Injury  

Event Description

It was reported that: patient has been experiencing pain since rehabilitation post surgery.Patient is reporting being unable to put on her sock and experiencing fatigue.She is experiencing swelling and problems walking.Patient is also reporting that she is limping.Patient states that she has been tested for chromium and cobalt, and had x-rays, and had mris done.Patient is also reporting that she is scheduled for revision surgery.Patient states that she will fax the implant sheet.Update submitted by sales rep - (b)(6) 2012: it was reported that, rejuvenate revision with mri (positive) findings per surgeon.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock met specifications.The complaint history review indicated that there have been similar events for the reported family.The event was confirmed.A voluntary recall ra2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.

• Brand Name: REJUVENATE MODULAR NECK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS CORK; carrigtwohill, cork ; EI
• Manufacturer (Section G): STRYKER ORTHOPAEDICS CORK; ida industrial estate; carrigtwohill, cork ; EI
• Manufacturer Contact: keyla navedo ; 325 corporate dr.; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3600500
• MDR Text Key: 4095191
• Report Number: 9616680-2014-00101
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: NLV-340800Y
• Device Lot Number: 27305402
• Other Device ID Number: 0810BM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RA2012-067
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 116