MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Death (1802); Nausea (1970); Thrombosis (2100); Vomiting (2144)

Event Date 12/13/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 42502006001, femur cemented cruciate retaining, lot # 64196777, catalog #: 42512100412, articular surface medial congruent, lot # 63998720, catalog #: 42540000032, all poly patella cemented, lot # 64208861.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient has died.The investigation is in process.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.Multiple mdr reports were filed for.This event, please see associated reports: 3007963827-2019-00106, 0001822565-2019-01574, 3007963827-2019-00107, 0002648920-2019-00273 remains implanted.

Event Description

It was reported that the patient underwent an initial left knee on approximately four months ago.The patient died on postop day three due to unknown reason.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected 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 patient experienced abdominal pain, bloating, nausea, shortness of breath, and vomiting post-operatively day two and morning of day three.Subsequently, the patient expired on post-operative day three due to procedural related complications including deep vein thrombosis (dvt) and possible pulmonary embolism (pe).However, this was unable to be tested due to the patient condition.It was also noted that there were occlusive and non-occlusive thrombus located in the femoral vein as well as non-occlusive thrombus located in other areas.

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as patient had died.X-rays showed normal appearance of left tka.Device history record was reviewed and no discrepancies relevant to the reported event were found.Reported issues are related to the procedure and are not abnormal to the procedure.No failure detected with the devices.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 further event information available at the time of this report.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT
• 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: 8523542
• MDR Text Key: 142238983
• Report Number: 0001822565-2019-01574
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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: 42530006401
• Device Lot Number: 77007007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• 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): Death
• Patient Weight: 64