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

Model Number N/A

Device Problems Device Slipped (1584); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Arthritis (1723); Unspecified Infection (1930)

Event Type  Injury  

Event Description

International orthopaedics (sicot) (2013) 37:31-37 doi: 10.1007/s00264-012-1710-7 pietschmann, m.Et al.Information was received based on review of a journal article titled, "sports activities after medial unicompartmental knee arthroplasty oxford iii - what can we expect?" which aimed to evaluate the long-term results for sports and physical activities of patients who had undergone implantation of an oxford iii medial unicompartmental knee arthroplasty (uka) in a minimally invasive technique.The hypothesis was that after oxford iii uka implantation for medial osteoarthritis of the knee, there would be an improvement in sports/physical activities.The oxford iii uka implant was manufactured at biomet.The study was conducted over a period of nine (9) years (1998 to 2007) and involved one-hundred seventy-one (171) patients who received one-hundred eighty-one (181) knees.The journal article reports the following revisions by reason: five (5) revisions due to osteoarthritis one (1) revision due to loosening one (1) revision due to instability with insert dislocation one (1) revision due to dislocation two (2) revisions due to impingement one (1) revision due to infection the authors of the study conclude that they could demonstrate that physically active patients with an oxford iii prosthesis have less pain and show higher clinical scores.However, since they could not find significant differences in radiological and objective scores between these groups, it remains unclear if this is a result of a ¿successful¿ implantation or if the activity itself is the reason for the better outcome.

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 article was written by pietschmann mf, et al in int orthop.2013 jan;37(1):31-7.Doi: 10.1007/s00264-012-1710-7.It is likely that these complications and revisions have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

• Brand Name: UNKNOWN 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: 4929310
• MDR Text Key: 6032857
• Report Number: 0001825034-2015-03164
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• 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?: Yes
• Date Manufacturer Received: 06/30/2015
• 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): Hospitalization; Required Intervention