MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MODULAR SPLINED STEM 40MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Examination of device found evidence of product non-conformance.The parts returned contained an undersized taper found to be nonconforming.Most likely evidence of a manufacturing process deficiency.It was determined to be an isolated incident.

Event Description

It was reported a patient underwent an initial knee arthoplasty procedure on (b)(6) 2015.During the procedure, it was reported that position of the stem pin and tray hole did not match causing the tray and the stem to not fit well.There was a gap between the stem and the plate so the press fit was shallower than usual.The surgeon thought the pin might be pressed obliquely so he tried to disconnected the stem and the tray but could not.He felt that they were well fixed and he decided to neatly tighten post screw to complete the procedure.No adverse event occurred.

• Brand Name: MODULAR SPLINED STEM 40MM
• 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: 5322741
• MDR Text Key: 34922704
• Report Number: 0001825034-2015-05105
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK080361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 141369
• Device Lot Number: 419570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2015
• 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