MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD COMPLETE KNEE SYSTEM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "seven-year survivorship and functional outcomes of the vanguard complete knee system¿ which followed 957 knees (865 patients) and examined the mid-term outcomes of high-flexion total knee replacements.The study was conducted over a period of five (5) years (march 2004 to november 2009) and involved nine-hundred fifty-seven (957) biomet vanguard knees in eight-hundred sixty-five (865) patients.The journal article reports that seventeen (17) revision procedures occurred due to the following reasons: eight (8) revisions due to infection.Seven (7) revisions due to aseptic loosening.One (1) revision due to dislocation.One (1) revision performed at a different location for an unknown reason.The authors of the study conclude that mean flexion improved from pre-operative range of motion to the flexion reported at final follow-up.Ninety percent (90%) of the knees achieved greater than 120° flexion.Further work will be required to confirm whether high flexion knees, in general, provide functional benefit over conventional knee designs.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Date of event - unknown.Catalog number, lot number and expiration date - unknown.Date implanted - unknown.Date explanted - unknown.Initial reporter - the article was written by william c schroer, m.D., daniel m.Stormont, m.D and william s.Pietrzak, ph.D.Seven-year survivorship and functional outcomes of the vanguard complete knee system.510k number - unknown.Manufacture date ¿ unknown.

• Brand Name: VANGUARD COMPLETE KNEE SYSTEM
• 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: 4173316
• MDR Text Key: 21172320
• Report Number: 0001825034-2014-08055
• Device Sequence Number: 1
• Product Code: HRY
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2014

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/15/2014
• 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