MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE

Catalog Number 00584202108

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It is reported that the surgeon was unable to properly seat the articular surface.The surgery was completed with another device.

Manufacturer Narrative

This report wil be amended when our investigation is complete.

Manufacturer Narrative

Upon insertion of articular surface the surgeon verbalized that he was unable to seat the articular surface component properly.After multiple attempts to insert and clip down with articular inserter, the surgeon requested another articular surface.A visual examination of the product shows heavy gouging in the rail where the component is supposed to align with the rail of the tibial component and seat.This device is used for treatment.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

No devices were received; therefore the condition of the components is unknown.Review of the device history records did not find any deviations or anomalies.A product history search identified no other complaints for this part and lot combination and no other complaints from this surgeon.A definitive root cause cannot be determined with the information provided; however, the complaint may be reopened upon return of product or further information.

• Brand Name: ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708 ; warsaw IN 46581
• Manufacturer Contact: kevin escapule ; 8006136131
• MDR Report Key: 4603059
• MDR Text Key: 5468927
• Report Number: 1822565-2015-00280
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 00584202108
• Device Lot Number: 62761281
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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 Age: 48 YR