MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM 8MM X 83MM; PROSTHESIS, SHOULDER

Catalog Number 113628

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Product was not returned; however, photos were received which confirm the reported issue.Review of device history records show the lot released with no recorded anomaly or deviation.Investigation results concluded that the reported event was due to a previously addressed labeling issue.

Event Description

It was reported that the patient labels inside the product packaging did not match the box label or product identification for the humeral stem needed for an initial shoulder arthroplasty.There was no delay and the product was used to complete the procedure.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM 8MM X 83MM
• 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: 6385732
• MDR Text Key: 69324791
• Report Number: 0001825034-2016-03862
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 113628
• Device Lot Number: 523080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 46 YR