MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED PRECOAT TIBIAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Material Discolored (1170)

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

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Please reference initial report first submitted for this event on mdr #1822565-2016-00326.No devices were returned.Photographs of the tibial component reviewed confirmed the presence of dark patches on the surface of the tibial plate.The patches were observed near the etched part and lot information and near the poly plugs on the opposite side.A stock investigation identified that there were no other units from this lot available for evaluation.Review of the device history records identified no deviations or anomalies.This device is used for treatment.A product history search identified no other complaints for this part and lot combination.A review of the manufacturing process for this device was conducted for this complaint.The investigation reviewed the applicable manufacturing steps and confirmed that appropriate controls are in place, and there were no nonconformities noted during the manufacturing steps for this lot number.An assignable cause could not be determined as the unit was not returned for evaluation and no discrepancies were found in the manufacturing process.As a result of this investigation, awareness was provided to the manufacturing operators and internal risk management documentation was reviewed and updated.

Event Description

It is reported that the implant was opened for surgery and upon inspection dark marks were found on the surface.Another nexgen tibia was used to complete the surgery.

• Brand Name: NEXGEN STEMMED PRECOAT TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5697999
• MDR Text Key: 46514050
• Report Number: 0002648920-2016-00867
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598003701
• Device Lot Number: 63111058
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1