MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER OPTION TYPE 1 TPR SLEVE 0; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem Unspecified Infection (1930)

Event Date 09/22/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial left total hip arthroplasty on (b)(6), 2014.Subsequently, the patient was revised on (b)(6), 2014 due to possible infection.During the procedure, the liner removal tool cut into the polyethylene liner and deformed it in a way that it could not be removed from the acetabular cup.The acetabular cup, polyethylene liner, taper and head were replaced.There was no significant delay as a result.

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: ¿early or late postoperative infection and allergic reaction.¿ this report is number 4 of 4 mdrs filed for the same event (reference 1825034-2014-08324, 08326, 08332 & 08333).

• Brand Name: CER OPTION TYPE 1 TPR SLEVE 0
• Type of Device: PROSTHESIS, HIP
• 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: 4206877
• MDR Text Key: 21313550
• Report Number: 0001825034-2014-08333
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 650-1066
• Device Lot Number: 340540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• 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: 67 YR