MAUDE Adverse Event Report: ZIMMER, INC. PERSONA FEMORAL POROUS COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.Received but not yet evaluated.

Event Description

It is reported that the patient underwent an arthroscopy and then was revised due to pain, swelling, tightness, limited mobility as well as femoral loosening and tibial lucency.

Manufacturer Narrative

Upon receipt of additional information, it was determined this report is a duplicate of 0001822565-2016-01349.This report was submitted in error and should be voided.

• Brand Name: PERSONA FEMORAL POROUS COMPONENT
• 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6096106
• MDR Text Key: 59715464
• Report Number: 0001822565-2016-04167
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK122745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502206401
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Date Manufacturer Received: 05/03/2016
• 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: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR