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

Device Problem Nonstandard Device (1420)

Patient Problem Pain (1994)

Event Date 09/01/2010

Event Type  Injury  

Event Description

It was reported that patient complains of pain since the surgery.Patient stated that she has attended rehab and pain management, but nothing has helped her.Patient has rec'd recall letter.Patient will look into another surgeon as her primary surgeon is no longer at that hospital.

Manufacturer Narrative

The catalog and lot number along with the device were not provided for investigation.The event is 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/ABG II HIP NECK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS CORK; carrigtwohill n/a; cork ; EI
• Manufacturer (Section G): STRYKER ORTHOPAEDICS CORK; carrigtwohill n/a; ida industrial estate; cork ; EI
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3569478
• MDR Text Key: 4051412
• Report Number: 9616680-2013-90289
• Device Sequence Number: 1
• Product Code: JDI
• 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
• 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: 01/03/2014
• 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: 12/18/2013
• 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: 48 YR
• Patient Weight: 82