MAUDE Adverse Event Report: ZIMMER INC ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT; HSX

Catalog Number 00584201401

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).The part and lot numbers are unknown; therefore the device history records could not be reviewed.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 for the patient's pain cannot be determined with the information provided.

Event Description

It is reported that the patient is experiencing loosening and pain.

Manufacturer Narrative

Other device used: catalog #00584200201, zimmer unicompartmental precoat tibial component, lot #62828702.This report will be amended when our investigation is complete.

Manufacturer Narrative

The device history records for the devices were reviewed for deviations and/ or anomalies with no issues identified.A definitive root cause remains unknown.

• Brand Name: ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT
• Type of Device: HSX
• 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: 5035358
• MDR Text Key: 24280493
• Report Number: 1822565-2015-01602
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/05/2015

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 Catalogue Number: 00584201401
• Device Lot Number: 62806594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2014
• 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): Other
• Patient Weight: 82