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 Angina (1710); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Dizziness (2194); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

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 and the other cases of infection being performed at different hospitals by different surgeons.Review of device history records found these units were released to distribution with no deviations or anomalies.Condition is addressed in package insert.Device not returned; inconclusive-root cause cannot be determined; known inherent risk of procedure.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 right partial knee arthroplasty on (b)(6) 2006.Subsequently, on (b)(6) 2006 the patient experienced a pulmonary embolism which was resolved on (b)(6) 2007.In (b)(6) 2007 the patient reported a superficial infection requiring antibiotics that was resolved on (b)(6) 2007.On (b)(6) 2007 the patient reported experiencing pain, numbness, trouble straightening their knee.On (b)(6) 2008 the patient reported that the left knee was a little painful and that they were experiencing dizzy spells.On (b)(6) 2014 the patient reported experiencing stiffness in her knee.Finally, the patient also reported angina on (b)(6) 2007 which was ongoing as of (b)(6) 2014.

• 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: 6965239
• MDR Text Key: 89845808
• Report Number: 0001825034-2017-09338
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 159575
• Device Lot Number: 1217659
• 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: 08/21/2006
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 70