MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF ANAT BRG LT X-SM SZ 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/20/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a left partial knee arthroplasty on (b)(6), 2014.Subsequently, patient underwent a revision procedure on (b)(6), 2014 due to a medial tibial plate fracture.During the revision procedure, a poly swap was performed.A review of the invoice history confirmed the initial surgery date; however, a revision invoice could not be located to confirm the revision procedure and which components were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that these types of events can occur: under possible adverse effects, number 14 states, "fatigue fracture of components can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: OXF ANAT BRG LT X-SM SZ 5 PMA
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 3947857
• MDR Text Key: 4644995
• Report Number: 0001825034-2014-06316
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 159792
• Device Lot Number: 085320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2013
• 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: 72 YR