MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK UNKNOWN RIGHT REJUVENATE/ABGII HIP NECK; IMPLANT

Device Problem Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994)

Event Date 09/20/2010

Event Type  Injury  

Event Description

It was reported that; pt is experiencing pain.Pt stated that he "feels like it is going to pop", patient is experiencing clicking in the joint area.Pt reported that he fallen several times because hip has given out.Pt stated that he might need revision surgery.Pt had tests and is following up with doctor.

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.

• Brand Name: UNKNOWN RIGHT REJUVENATE/ABGII 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 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3571432
• MDR Text Key: 20987806
• Report Number: 9616680-2013-90201
• 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?: No
• Is the Device Single Use?: No
• 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: 79 YR
• Patient Weight: 73