MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN CR-FLEX GSF FEMORAL COMPONENT

Catalog Number 00575201502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Fall (1848); Pain (1994)

Event Date 02/25/2015

Event Type  Injury  

Event Description

It is reported that the pt was revised due to pain and loosening of the femoral and tibial components.The pt fell 3 months prior to the revision.

Manufacturer Narrative

Info was received from a foreign source who is not required to complete form 3500a.This report will be amended when our investigation is complete.

Manufacturer Narrative

This report is being amended to reflect changes.

Manufacturer Narrative

Surgical notes were not provided.X-rays were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Attempts have been made to obtain additional information however, no further information has been received to date.A definitive root cause cannot be determined with the information provided.Review of the device history records did not find any deviations or anomalies.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the investigation, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

• Brand Name: NEXGEN CR-FLEX GSF FEMORAL COMPONENT
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46580 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 4647933
• MDR Text Key: 5602573
• Report Number: 1822565-2015-00439
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 00575201502
• Device Lot Number: 60976948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAT#00593004002, LOT#60953930,; NEXGEN CRR-FLEX MOBILE BEARING TIBIAL COMPONENT,
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 69