MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIOMET COMPREHENSIVE SEGMENTAL REVISION SYSTEM HUMERAL COMPONENT; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sperling et al.¿comprehensive srs'' journal article draft manuscript.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It is reported in a journal article that one (1) patient was treated with an allograft prosthetic composite during a revision due to periprosthetic fracture 3.6 years following shoulder arthroplasty.No further adverse consequences were reported.Attempts have been made to retrieve additional information, but no further information is available at this time.

Manufacturer Narrative

This follow-up report is being filed to correct information.Upon reassessment of the reported event, it was determined to not be reportable.A revision has been indicated due to patient anatomy and health issues and is not related to a product issue.

• Brand Name: UNKNOWN BIOMET COMPREHENSIVE SEGMENTAL REVISION SYSTEM HUMERAL COMPONENT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6710311
• MDR Text Key: 79923726
• Report Number: 0001825034-2017-04884
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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