MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK REJUVENATE MODULAR NECK 38MM; IMPLANT

Catalog Number NLV-380800Y

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/01/2012

Event Type  Injury  

Event Description

It is reported that: the patient began experiencing soreness in her hip and difficulty moving her leg in (b)(6) 2012.She received cortisone shots in (b)(6) 2012 which alleviated the pain.The pain returned in (b)(6) 2012 and has gotten increasingly worse.She is in constant pain.The patient reports trouble walking and a loss of mobility.She now uses a cane.The patient visited her surgeon in (b)(6) 2012.She had an mri of her hip and lab work completed on (b)(6) 2012.She is awaiting the results.Additional event description provided by sales rep - (b)(6) 2012: it was reported: rejuvenate revision.

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 38MM
• 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: 3600498
• MDR Text Key: 4094682
• Report Number: 9616680-2014-00102
• 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: 06/30/2015
• Device Catalogue Number: NLV-380800Y
• Device Lot Number: 32791801
• Other Device ID Number: 1006WCM
• 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: 06/30/2010
• 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
• Patient Age: 63 YR
• Patient Weight: 108