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

Catalog Number NLS-340000B

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/02/2012

Event Type  Injury  

Event Description

It was reported that, "painful, swelling hip.".

Manufacturer Narrative

Eval summary: a visual inspection was performed as part of the mar.The neck to stem trunnion of the modular neck exhibited evidence of micro-motion and corrosion indicating the presence of a mechanically assisted corrosion process.The surface most affected was the medial side of the neck to stem trunnion.The neck to head trunnion exhibited evidence of a pitting corrosion process.Device history review: review of the device history records indicates all devices accepted into final stock met specs.Complaint history review: the product experience reporting database shows there have been similar events reported for the product family.This issue has been previously investigated and addressed.Conclusions: voluntary recall ra (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision due to pain is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: LRG TAP PRI MOD NCK 0 DEG 34MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS MAHWAH; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS MAHWAH; 325 corporate dr; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate dr; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4375221
• MDR Text Key: 5239844
• Report Number: 9616680-2014-00400
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2014

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: 09/30/2015
• Device Catalogue Number: NLS-340000B
• Device Lot Number: 33271202
• Other Device ID Number: 1009BCM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 82 YR