MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN OXFORD KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Break (1069); Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported patient underwent a partial knee arthroplasty in (b)(6) 2014.Subsequently, patient alleges pain, snapping, implant moving and protruding out of the right side.There has been no reported revision procedure to date.

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.Brand name.Product / lot code / expiration date.Date of implant- (b)(6) 2014.Pma/510(k) number.Manufacture date.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "intraoperative or postoperative bone fracture and/or postoperative pain." and "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, excessive weight, and/or excessive unusual and/or awkward movement and/or activity.".

• Brand Name: UNKNOWN OXFORD KNEE
• 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: 4502205
• MDR Text Key: 19768523
• Report Number: 0001825034-2015-00510
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• 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): Required Intervention
• Patient Age: 90 YR