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

Catalog Number 4845-4-416

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/16/2012

Event Type  Injury  

Event Description

(b)(6).Update: from sales rep that, surgeon revised patient's right hip due to pain.Surgeon removed an abg ii 135 degree size 5 modular stem, 32d liner and 32 minus 25 ceramic biolox delata head.The 50 titanium cup stayed implanted.

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 an 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 LONG 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 drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3650203
• MDR Text Key: 4316795
• Report Number: 9616680-2014-00364
• Device Sequence Number: 1
• Product Code: KWY
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 4845-4-416
• Device Lot Number: G3007453
• Other Device ID Number: 20103361A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: RA 2012-067
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 70