MAUDE Adverse Event Report: ZIMMER INC NEXGEN CR-FLEX POROUS FEMORAL COMPONENT; MBH

Catalog Number 00595201601

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No devices or pictures have been returned for review.The device history records for the femoral implant were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.This device is used for treatment.Surgical notes were not provided.X-rays were not provided; it is unknown whether the devices were implanted with the correct fit and orientation as per the surgical technique.A complaint history search found no other complaints against the femoral implant part/lot combination.Compatibility of the implants was reviewed with no issues found.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported that the patient's components "began to degrade, loosen, and fail.".

• Brand Name: NEXGEN CR-FLEX POROUS 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: 5085933
• MDR Text Key: 26110276
• Report Number: 1822565-2015-01936
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00595201601
• Device Lot Number: 60063377
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other