MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN EXTREMITY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patients mentioned in the journal article.Initial reporter - the article was written by kachooei et al in the injury, int.J.Care injured (2016), http://dx.Doi.Org/doi:10.1016/j.Injury.2016.02.023.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "factors associated with removal of a radial head prosthesis placed for acute trauma, which tests the hypothesis that there are no factors associated with removal or revision of a radial head prosthesis; and analysis addressing the time to removal or revision using biomet product.A patient identified in the article underwent a left total elbow arthroplasty on an unknown date.Subsequently, the patient was revised 15 months post-op due to limited range of motion and heterotrophic ossification.

• Brand Name: UNKNOWN EXTREMITY
• Type of Device: PROSTHESIS, SHOULDER
• 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: 5554365
• MDR Text Key: 42064009
• Report Number: 0001825034-2016-01181
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• 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 EXTREMITY
• 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: 03/11/2016
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR