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

Device Problem Nonstandard Device (1420)

Patient Problems Emotional Changes (1831); Inadequate Pain Relief (2388)

Event Date 02/10/2012

Event Type  Injury  

Event Description

It is reported that: the pt had a total hip replacement done on (b)(6) 2012.Around (b)(6) 2012, he noticed his pain was not improving.He contacted his surgeon who said that this was normal.During his visit to his surgeon, he was informed that his hip had been recalled by stryker.The pt reports feeling helpless and states that the thought of revision surgery sends him into manic depression.His surgeon does not think he has the fretting problem that initiated the recall.He was advised by his surgeon to take a two-week rest from the exercise regimen, which he did.He still has the pain.He has already had an x-ray.He is scheduled to have blood work and an mri.The pt states that his pain is at the implant site and sometimes extends to the front of the hip.He has pain sitting, standing and walking for long periods of time; the more intense his activity, the more intense the pain.He takes an over the counter anti-inflammatory which provides some relief.

Manufacturer Narrative

Eval summary: the catalog and lot number along with the device were not provided for investigation.The event was confirmed.A voluntary recall ra 2012-67 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 HIP - REJUVENATE/ABGII 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: 3601408
• MDR Text Key: 4193710
• Report Number: 9616680-2014-00075
• 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
• 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
• 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
• 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: 64 YR
• Patient Weight: 113