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

Catalog Number 4845-4-411

Device Problem Noise, Audible (3273)

Event Date 10/01/2010

Event Type  Injury  

Event Description

It was reported that primary surgery was a stryker hip on (b)(6) 2010.She didn't feel right from the beginning and she didn't feel right on her first year check up.She had cortisone shots then and more shots in (b)(6) 2011.She had an mri when she noticed her hip was making noise.She had a revision on (b)(6) 2012.".

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 ra 2012-067 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: ABGII 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: 3625150
• MDR Text Key: 4174136
• Report Number: 9616680-2014-00309
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 4845-4-411
• Device Lot Number: G2996392
• Other Device ID Number: 20101821A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 68