MAUDE Adverse Event Report: ZIMMER INC ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT

Catalog Number 00584201502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 03/04/2010

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.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.The information from the patient confirms that the patient underwent a partial right knee arthroplasty.It was reported that the post-operative x-ray revealed that the knee had come apart.The information from the patient also confirmed that the patient underwent a revision total right knee arthroplasty.Product history search revealed no additional complaints against the related part and lot combination.A definitive root cause cannot be determined with the information provided.

• Brand Name: ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT
• 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: 4927642
• MDR Text Key: 15903218
• Report Number: 1822565-2015-01224
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 00584201502
• Device Lot Number: 61328307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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
• Treatment: ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE,; CATALOG #00584202508, LOT #60878683; ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT,; CATALOG # 00584200502, LOT #61079902
• Patient Outcome(s): Other
• Patient Age: 70 YR