MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK LRG TAP PRI MOD NCK 0DEG 30MM; IMPLANT

Catalog Number NLS-300000B

Device Problem Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 05/18/2011

Event Type  Injury  

Event Description

It was reported that: patient is experiencing pain in his left hip along with inflammation.Patient states that the pain started a month ago along with hearing a grinding and squeaking noise.Patient is reporting that he has seen the surgeon, has had the blood work, mri and x-rays done and is awaiting results.

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: LRG TAP PRI MOD NCK 0DEG 30MM
• 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: 3600508
• MDR Text Key: 4094210
• Report Number: 9616680-2014-00095
• 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: 10/31/2015
• Device Catalogue Number: NLS-300000B
• Device Lot Number: 34095901
• Other Device ID Number: 1010PCM
• 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: 10/22/2010
• 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: 58 YR
• Patient Weight: 109