MAUDE Adverse Event Report: ZIMMER INC ZIMMER UNICOMPARTEMENTAL ARTICULAR SURFACE

Catalog Number 00584202208

Device Problem Delamination (2904)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 07/14/2014

Event Type  Injury  

Event Description

It is reported that the patient was revised due to pain.After the articular surface was removed it was found to be delaminated and discolored.Osteolysis was also reported.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER UNICOMPARTEMENTAL ARTICULAR SURFACE
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4106488
• MDR Text Key: 4763016
• Report Number: 1822565-2014-01087
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 00584202208
• Device Lot Number: 62284952
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 60