MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIO-MOD HUM HEAD 48DIAX27MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 02/24/2014

Event Type  malfunction  

Event Description

It was reported patient underwent a total shoulder arthroplasty on (b)(6) 2014.During the procedure, it was noted the incorrect product was packaged for the humeral head.Another humeral head was utilized to complete the procedure without delay.

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.The reported event was confirmed.Investigation into the issue determined that this was an isolated incident.A review of transaction history revealed that the issue occurred during return/repack of the item and that there was no ¿mixed order¿ at the time of production.

• Brand Name: BIO-MOD HUM HEAD 48DIAX27MM
• 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: 3953512
• MDR Text Key: 4642586
• Report Number: 0001825034-2014-06399
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 113771
• Device Lot Number: 726290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2007
• 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