MAUDE Adverse Event Report: ZIMMER, INC. NATURAL KNEE FLEX FEMORAL COMPONENT; MBH

Catalog Number 00541201601

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 09/22/2014

Event Type  Injury  

Event Description

It is reported that the patient was revised due to loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Device history records were reviewed and no deviations or anomalies were found.This device is used for treatment.Primary surgery notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Review of the revision operative notes confirms that the patient underwent a left revision total knee arthroplasty due to a loose femoral component.An abundant amount of synovitis was removed.The surgeon stated that the "femoral component appears to be fairly welded to the distal femur".Some fibrous material surrounding the edges of the femoral component was found and the femoral component was explanted using a series of osteotomes and extractor.Minimal bone loss was noted.The package insert states that loosening is an adverse effect.This is therefore a known inherent risk of the procedure.A product history search revealed no additional complaints against the related part and lot combinations.A definitive root cause cannot be determined with the information provided.

• Brand Name: NATURAL KNEE FLEX FEMORAL COMPONENT
• Type of Device: MBH
• 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: 4944993
• MDR Text Key: 20805067
• Report Number: 1822565-2015-01316
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 00541201601
• Device Lot Number: 61103111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2008
• 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: 56 YR
• Patient Weight: 138