MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE PROVISIONAL; KNEE INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00826, 0001822565 - 2018 - 00827, 0001822565-2018-00828, 0001822565-2018-00829, 0001822565-2018-00830 , 0001822565 - 2018 - 00831, 0001822565 - 2018 - 00832, 0001822565 - 2018 - 00833, 0001822565 - 2018 - 00834, 0001822565 - 2018 - 00835, 0001822565 - 2018 - 00836, 0001822565 - 2018 - 00837, 0001822565 - 2018 - 00838, 0001822565 - 2018 - 00839, 0001822565 - 2018 - 00841, 0001822565 - 2018 - 00842, 0001822565 - 2018 - 00843, 0001822565 - 2018 - 00844, 0001822565 - 2018 - 00845, 0001822565 - 2018 - 00846, 0001822565 - 2018 - 00848, 0001822565-2018-00849, 0001822565-2018-00850, 0001822565 - 2018 - 00851, 0001822565 - 2018 - 00852.

Event Description

It was reported that the provisional instrument was fractured.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as the returned devices were fractured.Device history record was reviewed and no discrepancies were found.All products had possible field lives of over 10 years and all show heavy signs of wear and tear and most are cracked, therefore root cause was determined to be wear and tear over a successful field life.The likely condition of the parts when they left zimmer biomet control is considered conforming based on the device history review and rir review.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 ARTICULAR SURFACE PROVISIONAL
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7292194
• MDR Text Key: 101010285
• Report Number: 0001822565-2018-00844
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• 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: 00599504217
• Device Lot Number: 72400100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1