MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN CEMENT BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/12/2016

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. The following sections could not be completed with the limited information provided: brand name ¿ ni. Device code - ni. Device info - ni. Pma/510(k) number ¿ ni. Manufacture date ¿ ni. This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-03864 / 03865).

Event Description

It was reported the patient underwent a revision procedure approximately thirteen years post-implantation due to loosening of the patella button. The surgeon noted the cement and patella button failed, which resulted in the patella button loosening. The polyethylene bearing and patella button were removed and replaced.

• Brand Name: UNKNOWN CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: 5987389
• MDR Text Key: 55940409
• Report Number: 0001825034-2016-03865
• Device Sequence Number: 1
• Product Code: MBB
• 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

• Type of Report: Initial
• Report Date: 08/30/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/29/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes

Device Operator

• Device MODEL Number: N/A
• OTHER Device ID Number: N/A
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/30/2016
• 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 TREATMENT DATA

Date Received: 09/29/2016 Patient Sequence Number: 1