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

Catalog Number NLS-3800000B

Device Problems Nonstandard Device (1420); Metal Shedding Debris (1804)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 01/22/2010

Event Type  Injury  

Event Description

It was reported that; the pt reports no problems in the hip, but stiffness in the left leg.He cannot bend his knee.His thigh muscles stiffen when he stands for a while and he experiences intense pain.The pt had an appointment with his physician on (b)(6) 2012.He had an mri and blood test for chromium and cobalt levels.The pt states the surgeon reported some elevated metal levels in his blood.The surgeon will monitor his condition and re-test him in (b)(6) 2013.

Manufacturer Narrative

A review of the device history records indicated that the reported devices were manufactured and accepted into the 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: REJUVENATE 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: 3601417
• MDR Text Key: 18303336
• Report Number: 9616680-2014-00046
• 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: 02/28/2013
• Device Catalogue Number: NLS-3800000B
• Device Lot Number: 24945401
• Other Device ID Number: 0802EM2
• 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: 02/07/2008
• 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: 47 YR
• Patient Weight: 102