MAUDE Adverse Event Report: ZIMMER INC NEXGEN CR-FLEX GSF FEMORAL COMPONENT; HTO

Catalog Number 00597909529

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2004

Event Type  malfunction  

Manufacturer Narrative

Dimensional/functional analysis found the reamer blade to be conforming to print specifications and accepted by the functional gages.The device was used for treatment.The surgical technique calls for the patella reamer blade and shaft to be inserted into the insetting guide before bringing he shaft up to full speed and to advance it slowly until the prominent high points are reamed off.The reported event cannot be confirmed.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the outside blade of the patella reamer is sitting slightly lower or on less of an angle, therefore one side was over-torquing.

• Brand Name: NEXGEN CR-FLEX GSF FEMORAL COMPONENT
• Type of Device: HTO
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5567991
• MDR Text Key: 42373749
• Report Number: 1822565-2016-01142
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00597909529
• Device Lot Number: 62740739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1