MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK LRG TAP PRI MOD NCK 0DEG 34MM; IMPLANT

Catalog Number NLS-340000B

Device Problem Nonstandard Device (1420)

Patient Problems Disability (2371); Test Result (2695)

Event Date 09/28/2012

Event Type  Injury  

Event Description

It was reported that, as per dr (b)(6) office, this pt is experiencing difficulties with their hip implant and has had blood tests.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock met specs.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: LRG TAP PRI MOD NCK 0DEG 34MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS CORK; carrigtwohill county cork ; EI
• Manufacturer (Section G): STRYKER ORTHOPAEDICS CORK; ida industrial estate; carrigtwohill county cork ; EI
• Manufacturer Contact: keyla navedo ; 325 corporate dr; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3601360
• MDR Text Key: 4190171
• Report Number: 9616680-2014-00089
• 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: Health Professional,Company Representative
• 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: 01/31/2017
• Device Catalogue Number: NLS-340000B
• Device Lot Number: 38893901
• Other Device ID Number: 1201RCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RA 2012-067
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR