MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT LG SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Death (1802); Pneumonia (2011); Urinary Tract Infection (2120)

Event Date 08/24/2013

Event Type  Death  

Event Description

It was reported that patient enrolled in a clinical study underwent partial knee arthroplasty on (b)(6) 2009.Cardiac arythmia of the patient occurred during the knee procedure on (b)(6) 2009 and was resolved on (b)(6) 2009.The patient then experienced a uti on (b)(6) 2009, which was also resolved on (b)(6) 2009.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

Manufacturer Narrative

This tibial bearing is not 510(k) cleared for use with the cementless high flex partial knee system and does not require medical device reporting per 21 cfr part 803.Please disregard this manufacturer report number.

Manufacturer Narrative

It has been determined through remediation review that this is now a reportable complaint, despite the fact that was rejected in 2016.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 an additional complaint for urinary tract infection (b)(4) that was investigated, and it was determined that no further action is required as the events were not confirmed to be related to the device or the procedure.Review of device history records found this unit was 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.Zimmer biomet complaint: (b)(4).

• Brand Name: OXF ANAT BRG LT LG SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridgend, south wales
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4782176
• MDR Text Key: 5819802
• Report Number: 0001825034-2015-02071
• 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: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• 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: 159554
• Device Lot Number: 1402387
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• 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; Hospitalization
• Patient Age: 84 YR
• Patient Weight: 97