MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL; PROSTHESIS KNEE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - unknown nexgen articular surface catalog # unknown lot # unknown, tibial baseplate component catalog # 00588605510 lot # 63208575, patella resurfaced catalog # 00587806535 lot # 63695060.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565 - 2018 - 00346.Remains implanted.

Event Description

It was reported that patient underwent an initial right knee procedure due to pain.Deep vein thrombosis was found postoperative six days while patient was awaiting extended care facility placement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following has been corrected: the following has been updated: reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per the persona knee system package insert, cardiovascular disorders including venous thrombosis, pulmonary embolism or myocardial infarction are known potential adverse effects of this procedure.A definitive root cause cannot 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.

Event Description

No additional information available at this time.

• Brand Name: PERSONA FEMUR TRABECULAR METAL
• 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: 7206847
• MDR Text Key: 97786139
• Report Number: 0001822565-2018-00366
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122745
• 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,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500806202
• Device Lot Number: 63680778
• Other Device ID Number: (01) 00889024469884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 98