MAUDE Adverse Event Report: STRYKER ORTHOPEDICS STRYKER REJUVENATE MODULAR NECK ; HIP IMPLANT

Model Number NLV-300800Y

Device Problem Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 02/20/2016

Event Type  Injury  

Event Description

This (b)(6) female pt underwent a total right hip arthroplasty under dr.(b)(6) here at (b)(6) hospital.A stryker rejuvenate modular stem and neck device were implanted.On 06/28/2012, stryker issues a voluntary recall of the stryker rejuvenate modular stem and neck.

• Brand Name: STRYKER REJUVENATE MODULAR NECK
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPEDICS; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5479594
• MDR Text Key: 39676219
• Report Number: 5479594
• Device Sequence Number: 1
• Product Code: JDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NLV-300800Y
• Device Lot Number: 24945201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2016
• Device Age: 4 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Weight: 41