MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL CUT GUIDE; PROSTHESIS KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event was initially reported on 0001822565-2020-02530 and 0001825034-2020-04179.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows the drill pin stuck in a hole.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

Event Description

It was reported that the drill pin got stuck to the device during an initial procedure.Attempt for further information has been made, but no further information has been provided.

• Brand Name: PERSONA TIBIAL CUT GUIDE
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11678493
• MDR Text Key: 245819096
• Report Number: 0001822565-2021-01039
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024582859
• UDI-Public: (01)00889024582859(10)64768305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: 42539905295
• Device Lot Number: 64768305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1