MAUDE Adverse Event Report: ZIMMER INC PERSONA TAPERED STEM EXTENSION; OIY

Catalog Number 42557000114

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that upon removal of tibia, the stem extension separated from base plate.The stem had to be chased down the im canal using a trephine to loosen from cement mantle.

Manufacturer Narrative

Other device used: catalog #42532007101, persona cemented stemmed tibia component, lot #62892259; manufactured at zimmer (b)(4).No devices and photos were received; therefore, the condition of the components is unknown.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.

• Brand Name: PERSONA TAPERED STEM EXTENSION
• Type of Device: OIY
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5113766
• MDR Text Key: 27183594
• Report Number: 1822565-2015-01985
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42557000114
• Device Lot Number: 62916242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2015
• 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