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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "mortality and perioperative complications after unicompartmental knee arthroplasty".This study aimed to determine the 90-day incidence of perioperative complications and mortality of patients undergoing total knee arthroplasty.The oxford phase iii mobile bearing unicompartmental knee prosthesis and the vanguard m fixed bearing unicompartmental knee prosthesis were used, both manufactured at biomet.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side and an unknown date.Subsequently, patient underwent manipulation under anesthesia due to inadequate range of motion and arthrofibrosis.There has been no further information provided and the patient outcome is unknown.

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.This information was originally reported on 1825034-2015-02797 which referenced a journal article written on a study that this patient took part in.

• 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: 4888839
• MDR Text Key: 6019241
• Report Number: 0001825034-2015-02798
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2015

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: 06/25/2015
• Initial Date FDA Received: 07/02/2015
• 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