MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NEXGEN FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number 00575001601

Device Problems Material Discolored (1170); Dent in Material (2526)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source- (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported that the implant had some material left on the device.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4 - udi# - (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product confirmed the presence of a stain on the color buffed surface and of a pit on the condylar surface in the notch area.Analysis of the stain concluded that it was caused by acetone transferred from the glove of the operator during pmma rework.Review of the device history record found a non-conformance report indicates that two parts underwent standard rework for pmma defect, which could be related to the reported event.Investigation results concluded that the reported event was due attributed to a manufacturing deficiency.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: NEXGEN FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 8245713
• MDR Text Key: 132990638
• Report Number: 3007963827-2019-00016
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K060370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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 Catalogue Number: 00575001601
• Device Lot Number: 64006846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1