MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF UNI TIB TRAY SZ B RM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 12/09/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a right partial knee arthroplasty on an unknown date.Subsequently, a revision was performed on (b)(6) 2014 due to a dislocated tibial bearing and a loose tibial tray.All components were removed and replaced with competitor product.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Lot number, expiration date - unknown; date implanted - unknown; manufacture date - unknown.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2014-09306 & 09325 / 09326).

• Brand Name: OXF UNI TIB TRAY SZ B RM 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: 4385969
• MDR Text Key: 5260209
• Report Number: 0001825034-2014-09306
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• 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: 154721
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• 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