MAUDE Adverse Event Report: ZIMMER, INC. PERSONA STEM EXTENSION TAPERED CEMENTED; KNEE PROSTHESIS

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Information was received via medwatch mw5061905.This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing pain and instability.Additionally, a hairline gap was seen on x-ray.A revision surgery is planned.

• Brand Name: PERSONA STEM EXTENSION TAPERED CEMENTED
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5735645
• MDR Text Key: 47735641
• Report Number: 0001822565-2016-02108
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 42557000114
• Device Lot Number: 62573188
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other