MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET ARCOM PATELLA BUTTON - ALL POLY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 01/24/2013

Event Type  Injury  

Manufacturer Narrative

(b)(6).(2016) "annual report for long-term multi-center evaluation of the vanguard e1 tibial bearing" agreement b091840, reporting march 30, 2016 through march 10, 2017.Concomitant devices: vanguard cr femoral 70mm right-interlok catalog #: 183012 lot #: ni, vanguard e1 antioxidant infused cr tibial bearing catalog #: ep-183464 lot #: ni, biomet cc cruciate tibial tray 79mm catalog #: 141235 lot #: ni.The study was performed at (b)(6) and involved eleven centers including: (b)(6).The authors involved in this study are currently unknown and it is unknown who performed the surgeries involved.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.This report is number 1 of 4 mdrs filed for the same patient (reference 0001825034-2017-04721 / 04722 / 04725).

Event Description

It is reported that one (1) patient underwent knee arthroplasty revision due to the development of sepsis twelve (12) days following implantation.Attempts have been made to retrieve additional information, but no further information is available at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Upon reassessment of the reported event based on additional information received, it was determined to be not reportable as only the polyethylene bearing was removed during the revision procedure.

• Brand Name: BIOMET ARCOM PATELLA BUTTON - ALL POLY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6695355
• MDR Text Key: 79353842
• Report Number: 0001825034-2017-04723
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK921182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-150824
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 09/15/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR