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

Model Number N/A

Device Problem Overcorrection (3006)

Patient Problems Death (1802); Deformity/ Disfigurement (2360); No Code Available (3191)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "radiological changes five years after unicompartmental knee replacement" which assessed the fate of the compartments and changes in leg alignment following a ukr.The study was conducted over a period of three (3) years (1989 to 1992) and involved forty-five (45) patients who received fifty (50) ukrs.Four (4) patients died during the study.The journal article reports the following events by reason: two (2) revisions occurring before review.Two (2) overcorrections of deformity in the coronal plane.One (1) progression of osteoarthritis within the patellofemoral joint.The authors of the study conclude that the incidence of progressive osteoarthritis within the knee was very low after ukr.Patients should be carefully selected and overcorrection of the deformity be avoided.

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.Initial reporter - the article was written by weale ae, murray dw, baines j, newman jh in j bone joint surg br.2000 sep;82(7):996-1000.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• 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: 4916527
• MDR Text Key: 6025657
• Report Number: 0001825034-2015-03004
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• 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: 10/16/2015
• 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