MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TIBIAL IMPACTOR; KNEE INSTRUMENT

Model Number N/A

Device Problem Flaked (1246)

Patient Problem No Information (3190)

Event Date 02/20/2018

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 will be submitted.

Event Description

It was reported that the rubber shavings came of the impactor while impaction with the trial tibial prosthesis during a right knee arthroplasty.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.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

It was further reported that the surgeon was impacting the impactor with a mallet when the rubber shavings fell into the patient's wound.All pieces were retrieved and no pieces were retained by the patient.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

Reported event confirmed via visual device evaluation.The device shows signs of wear out consistent with use.Also noted were signs of over-tightening of the screw.Device history record (dhr) review did not identify any related deviations or anomalies that would have contributed to the reported event.Root cause was unable to be determined.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.

• Brand Name: NEXGEN TIBIAL IMPACTOR
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7434314
• MDR Text Key: 105882460
• Report Number: 0001822565-2018-02159
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00597702500
• Device Lot Number: 63699911
• Other Device ID Number: (01)00889024216297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1