MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OSS POLYETHYLENE TIBIAL BUSHING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Collapse (1099)

Patient Problem Unspecified Infection (1930)

Event Date 05/11/2012

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a revision procedure on (b)(6) 2014, but did not give a reason for revision.Further follow up revealed that the patient underwent an initial knee procedure on an unknown date in which competitor product was implanted.The patient was revised to a biomet orthopedic salvage system on (b)(6) 2010 for an unknown reason.A second revision procedure was performed on (b)(6) 2012 due to collapse of the tibial components.All components were removed and replaced.Subsequently, two revision procedures were performed on (b)(6) 2012 due to infection.The bushings, bearings, axles, lock pins and yokes were removed and replaced during both revision procedures and the wound was irrigated.During the revision procedure performed on (b)(6) 2014, fracture of the femoral tabs was noted.All components were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative, infection, and allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 9 of 13 mdrs filed for the same event (reference 1825034-2014-07215 / 07218 & 07236 / 07245).

• Brand Name: OSS POLYETHYLENE TIBIAL BUSHING
• 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: 4031454
• MDR Text Key: 4883254
• Report Number: 0001825034-2014-07241
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/28/2014

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 Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 150476
• Device Lot Number: 273430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2012
• 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