MAUDE Adverse Event Report: BIOMET BIOLOGICS UNKNOWN TISSUE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/29/2016

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.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may occur.Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

Event Description

Patient has been indicated for a future revision due to allograft failure.No additional information has been provided.

Manufacturer Narrative

This follow-up report is being filed to correct information.

Event Description

Patient has been indicated for a future revision due to allograft failure.However, no revision procedure has been reported to date.No additional information has been provided.

• Brand Name: UNKNOWN TISSUE
• Manufacturer (Section D): BIOMET BIOLOGICS; 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: 5889940
• MDR Text Key: 52561236
• Report Number: 0001825034-2016-03183
• Device Sequence Number: 1
• Product Code: NUN
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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?: 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
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR