MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SEGMENTAL REVISION SYSTEM DISTAL BODY WITH SCREW-RIGHT 70MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.(b)(4).Medical product - disc condyle kit w/ hexalobula, catalog#: 114700 lot 721800; compr srs mod stem - 8x100mm, catalog#: 211236 lot 263930; compr srs small flange, catalog#: 211269 lot 652190; disc ulna 3x115mm rt w/brng c, catalog#: 114817 lot ni.Therapy date - (b)(6) 2016.

Event Description

During an elbow revision of competitor product, the distal humerus component would not fit with the condyle kit.A high speed burr was utilized to remove metal from the component to facilitate assembly.The medial condyle screw also remained proud and was tight.This event caused a 75 minute delay.

Manufacturer Narrative

This follow up report is being filed to relay additional information.No device or photos were received; therefore the condition of the device is unknown.Review of device history records revealed no deviations or anomalies.The instructions for use indicate the devices used are compatible.Complaint history search found no additional complaint for this device.A definite root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE SEGMENTAL REVISION SYSTEM DISTAL BODY WITH SCREW-RIGHT 70MM
• 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: 6145731
• MDR Text Key: 61458466
• Report Number: 0001825034-2016-05032
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211255
• Device Lot Number: 688560
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 63