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

Model Number N/A

Device Problems Device Slipped (1584); Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, " causes of failure after total knee arthroplasty in osteoarthritis patients (b)(6) of age or younger" " which compared the modes of failure after total knee arthroplasty in patients older than (b)(6) of age to those who are younger than (b)(6) who underwent revisions.The study reviewed four-hundred fifty-three (453) patients =(b)(6) of age at the time of primary tka between the years of 1992-2012.One-hundred sixty-nine (169) cases used maxim for the primary implant and fifty-nine (59) cases used vanguard.The journal article reports, thirty-one (31) patients underwent revision procedures, and that twelve (12) patients of the (31) revised knees were revised with maxim.In the =(b)(6) of age group, the most common cause of tka failure was polyethylene wear (45%) followed by infection (26%) and loosening (17%).There were relatively lower infection rate and higher loosening rate in patients = (b)(6) of age, but the difference was not statistically significant.It is not known which revision procedures reported involve biomet product.

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.It is not known the cause for patient's revised with biomet devices.Initial reporter - the article was written by kim kt, lee s, ko do, seo bs, jung ws, chang bk.Causes of failure after total knee arthroplasty in osteoarthritis patients 55 years of age or younger.Knee surg relat res.2014;26(1):13-19.

• Brand Name: UNKNOWN MAXIM 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: 4006552
• MDR Text Key: 4775555
• Report Number: 0001825034-2014-06984
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2014

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: 07/14/2014
• Initial Date FDA Received: 08/13/2014
• 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