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

Catalog Number 42502205801

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that patient had a knee arthroplasty revised due to pain and nickel allergy.

Manufacturer Narrative

Upon reassessment of the reported event, it has been determined to be a duplicate of mfr 0001822565-2015-01651.The initial 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: 6014185
• MDR Text Key: 56912445
• Report Number: 0001822565-2016-03632
• 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
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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 Catalogue Number: 42502205801
• Device Lot Number: 62614797
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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
• Patient Age: 70 YR