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

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 12/05/2016

Event Type  Injury  

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.Implanted on an unknown date in 2001.

Event Description

Patient has been indicated for a left knee revision of a custom prosthesis due to wear.No revision has been reported to date.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2017-04503.

• Brand Name: UNKNOWN CUSTOM DISTAL HINGED 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6218406
• MDR Text Key: 63731521
• Report Number: 0001825034-2017-00016
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• 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): Required Intervention