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

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/29/2011

Event Type  Injury  

Event Description

It was reported that pt is complaining of intense pain in his hip, groin, thighs, feet, and toes.His feet and toes are swollen.Pt states that his hip sometimes clicks when he walks.He has been in pain since surgery.He visited his doctor on (b)(6) 2012 and doctor scheduled bloodwork and xrays.Scheduled visit for test results.

Manufacturer Narrative

The catalog and lot number along with the device were not provided for investigation.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: UNKNOWN RIGHT REJUVENATE/ABG II HIP NECK
• 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 corp dr.; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3601423
• MDR Text Key: 4064104
• Report Number: 9616680-2014-00007
• 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: Consumer
• Reporter Occupation: 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2013
• 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: 54 YR
• Patient Weight: 89