MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the provisional was discovered to be fractured prior to entering the operating room.There was no patient involvement.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The device exhibits signs of repeated use the post has a fragment fractured off.Fragment not returned as they were discarded.Device history record was reviewed and no discrepancies were found.Surgical notes were not provided.Further investigation into this issue determined that the likely root cause for the tasp fractures is bending/torsional loading on the device.A notification was sent to the field to provide additional clarifications relating to the instructions for use of the tasp construct for all persona users on file at the time of the field notice.The root cause is considered to be a previously addressed design issue.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: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8377284
• MDR Text Key: 137379058
• Report Number: 0001822565-2019-00895
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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 Model Number: N/A
• Device Catalogue Number: 42527000707
• Device Lot Number: 62612281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2297-2014
• Patient Sequence Number: 1