MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ABSOLUTE BI-POLAR POLYETHYLENE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that patient underwent an orthopedic salvage shoulder procedure on an unknown date in 1994.Subsequently, patient underwent a revision procedure on (b)(6) 2004 due to an unknown reason.Patient underwent a further revision procedure on (b)(6) 2013 due to an unknown reason.Another revision procedure was performed on (b)(6) 2014 due to a fractured stem.A review of the invoice history confirmed the revision procedures; however, an invoice could not be located to confirm the initial surgery date.It further indicates that the liner was removed and replaced on (b)(6) 2013.Invoice history indicates patient was implanted with a biomet comprehensive segmental revision system on (b)(6) 2014.

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.This report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2014-05323, 05436 & 05437).

• Brand Name: ABSOLUTE BI-POLAR POLYETHYLENE
• Type of Device: PROSTHESIS, SHOULDER
• 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: 3868595
• MDR Text Key: 4455560
• Report Number: 0001825034-2014-05437
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002998
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 113169
• Device Lot Number: 571910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2013
• 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