MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG LT LG SIZE 3 PMA; PROSTHESIS - KNEE

Catalog Number 159554

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/09/2011

Event Type  Death  

Manufacturer Narrative

The product remained implanted, and therefore was not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.Review of the complaint history identified additional complaints that were investigated related to knee issues, and it was determined that no further action is required as the possibility of adverse effects are relayed to the patient before undergoing surgery.Lot identification is necessary for review of device history records, and it was not provided.Condition is addressed in package insert.Device not returned; inconclusive-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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that the patient underwent an initial partial left knee arthroplasty on (b)(6) 2006.Subsequently, the patient underwent a right total hip arthroplasty on an unknown date in (b)(6)of 2009 due to a fracture femoral neck.It is unknown how the fracture occurred or if the patient was implanted with zimmer biomet products.The patient reported shortness of breath on exertion and right knee problem on (b)(6) 2011.The patient passed away on (b)(6) 2011 due to unknown reasons.

• Brand Name: OXF ANAT BRG LT LG SIZE 3 PMA
• 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: 6954125
• MDR Text Key: 89464777
• Report Number: 0001825034-2017-08767
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 159554
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 75 YR
• Patient Weight: 75