MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 7; TEMPLATE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: 00598105701, provisional stemmed tibial component size 7, unknown; 00598105701, provisional stemmed tibial component size 7, unknown.Report source, foreign - the event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03158, 0001822565 - 2018 - 03159.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.

Event Description

It was reported that three tibial trials were discovered fracture during a knee arthroplasty procedure.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

The complaint samples were not evaluated and the reported event could not be confirmed.The device history records could not be reviewed as the lot numbers associated with the reported event were not provided.A definitive root cause could not be determined with the information provided.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 PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 7
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7595374
• MDR Text Key: 110846987
• Report Number: 0001822565-2018-03158
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00598105701
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1