MAUDE Adverse Event Report: CORIN, LTD. CORMET HIP RESURFACING; HIP RESURFACING PROSTHESIS

Model Number 570-05-052

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Device details, patient medical history, event information, explant and reason for revision have been requested in order to progress with the investigation.Device manufacturing records will be reviewed when appropriate device information has been provided.

Event Description

Revision of stryker rejuvenate hip stem with possible involvement (unconfirmed) of cormet cup and head.

• Brand Name: CORMET HIP RESURFACING
• Type of Device: HIP RESURFACING PROSTHESIS
• Manufacturer (Section D): CORIN, LTD.; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 5025441
• MDR Text Key: 23931571
• Report Number: 9614209-2015-00049
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 570-05-052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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): Hospitalization; Required Intervention