MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK UNKNOWN RIGHT STRYKER MODULAR HIP NECK; IMPLANT

Device Problems Nonstandard Device (1420); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 06/21/2007

Event Type  Injury  

Manufacturer Narrative

The event was confirmed.A voluntary recall (b)(4) 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.

Event Description

It was reported that; pt complains of pain since the surgery.She has also noticed some "clicking" along with the pain and movement of her hip.Pt stated that she has had several blood tests and mri.Mri showed a pseudotumor.Pt unsure of her implant type and will see her surgeon tomorrow as she will like to know if her implants have been subject to recall.

• Brand Name: UNKNOWN RIGHT STRYKER MODULAR HIP 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 corporation drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3571450
• MDR Text Key: 19391806
• Report Number: 9616680-2013-90194
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 67