MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS 2 PEG TIBIAL COMPONENT; OIY

Catalog Number 42530007101

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported that radiographs reveal a possible broken tibial plate.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Device history records were reviewed and no deviations or anomalies were found.No devices were received; therefore the condition of the components is unknown.This device is used for treatment.Office visit notes dated (b)(6) 2014 indicate that the patient had advanced osteoarthritis of the left knee.Physical examination found range of motion from 0 to 110 degrees with a synovial cyst, but no pedal edema in the left lower extremity.No pain was identified with varus valgus stresses.It was noted that the patient was scheduled for a left total knee arthroplasty to occur on (b)(6) 2014.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.After review of the provided x-rays, dr.(b)(6) does not believe the plate is fractured, but could be a result of the angle of the x-ray taken.Additional x-rays have not been taken to confirm the event.A definitive root cause cannot be determined with the information provided.

• Brand Name: PERSONA POROUS 2 PEG TIBIAL COMPONENT
• Type of Device: OIY
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4817819
• MDR Text Key: 5919307
• Report Number: 1822565-2015-00800
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 42530007101
• Device Lot Number: 62407621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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): Other