MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG LT LG SIZE 4 PMA; PROTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/11/2006

Event Type  Injury  

Manufacturer Narrative

Product was not returned to zimmer biomet for investigation.Without the opportunity to examine the complaint product, root cause cannot be determined.-review of device history records found these units were released to distribution with no deviations or anomalies.-review of the complaint history identified additional complaints that were investigated, and it was determined that no further action is required due to the time frame in which they were manufactured.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 partial left knee arthroplasty on (b)(6) 2006 subsequently, on (b)(6) 2007 the patient reported occasional stiffness in left knee, manipulation under anaesthesia - left knee, right knee symptomatic - very occasional and the left knee feels tight from time to time.On (b)(6) 2010 the patient reported episodes of swelling/pain in left knee medial and laterally after long walk.On (b)(6) 2013 it was reported that the patient's left knee was warm to the touch, generalised swelling and suprapatatellar swelling in left knee and tender lateral joint line- left knee.On (b)(6) 2013 the patient reported lateral knee swelling.

• Brand Name: OXF ANAT BRG LT LG SIZE 4 PMA
• Type of Device: PROTHESIS 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: 6957443
• MDR Text Key: 89572531
• Report Number: 0001825034-2017-09085
• 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: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 1202803
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2006
• 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): Other
• Patient Age: 65 YR
• Patient Weight: 88