MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG LT MD SIZE 3 PMA; PROTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); High Blood Pressure/ Hypertension (1908); Pain (1994); Seizures (2063); Swelling (2091); Visual Disturbances (2140); Dizziness (2194)

Event Date 12/02/2008

Event Type  Injury  

Manufacturer Narrative

Product was not returned to zimmer biomet for investigation.Not cleared for distribution in the us.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 the infrequency of the reports of cellulitis/delayed wound healing and the other reports of infection occurring at different hospitals with different surgeons.Review of device history records found these units were released to distribution with no deviations or anomalies.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 reported that the patient underwent left partial knee arthroplasty on (b)(6) 2008.Subsequently, on (b)(6) 2008 the patient reported feeling unwell for 3 days, left leg pain, and fever which resolved on (b)(6) 2009.On (b)(6) 2008 the patient reported cellulitis in the left calf which spread and produced collections in the left calf and the medial and posterior thigh.The patient reported making (b)(6) trips to the theater for plastic surgery to debride areas of neurotic tissue and drain the collections.The cellulitis was followed by the patient being admitted to the hospital intensive care unit due to overwhelming sepsis.The patient was intubated with a tracheostomy and had a nasogastric feeding tube for a few weeks.In (b)(6) 2008 the patient reported that klebsiella pseudomonas, and candida grew from the wounds in their left leg and their extensor tendon was exposed from severe cellulitis.The patient also had skin grafts put on their left leg to help the defects heal.The patient then experienced a seizure type episode due to post sepsis changes in their brain which resulted in confusion.The patient also experienced an episode of fast atrial fibrillation and an episode of non-st-elevation myocardial infarction.In (b)(6) 2009 the patient reported having a sore throat and swallowing problems from long term intubation, eczema, intertrigo in the axilla, groin, and glans penis, and visual problems in the right eye.On (b)(6) 2009 the patient developed (b)(6) which was resolved on (b)(6) 2009.On (b)(6) 2009 the patient was readmitted to the hospital for contact dermatitis caused by antiperspirants and herbal cream.On (b)(6) 2010 the patient reported tenderness and hypersensitivity in their left foot and dizziness when mobilizing.On (b)(6) 2012 the patient reported having cellulitis in the left leg with 10 days of the leg swelling, pain and erythema.The swelling was reduced by intravenous drugs.On (b)(6) 2012 the patient reported that they had a right groin hernia, ischaemic heart disease, and hypertension.On (b)(6) 2014 the patient reported having to undergo lymphatic drainage and massage to assist with pain in left lower leg.On (b)(6) 2015 the patient reported long term neuropathic pain in the dorsum of the left foot.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 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: 6933808
• MDR Text Key: 89156670
• Report Number: 0001825034-2017-08316
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 1573807
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 63