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

Catalog Number 159575

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pain (1994); Discomfort (2330)

Event Date 06/04/2015

Event Type  Death  

Manufacturer Narrative

The product 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, and it was determined that no further action is required due to pain being subjective to the patient.Review of device history records found these units were released to distribution with no deviations or anomalies.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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 clinical patient had an initial right partial knee procedure on (b)(6) 2008.Patient reported slow progress and discomfort in study knee on (b)(6) 2009.Patient also reported pain when kneeling on study knee on (b)(6) 2010.The patient expired on (b)(6) 2015 due to unknown reasons.An obituary was found online of the patient's passing.It is unknown if the implants were in situ at time of death.

• Brand Name: OXF ANAT BRG RT MD 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: 6954118
• MDR Text Key: 89464696
• Report Number: 0001825034-2017-08768
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• 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 Expiration Date: 08/31/2012
• Device Catalogue Number: 159575
• Device Lot Number: 1384556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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: 67 YR
• Patient Weight: 77