MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/03/2016

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 that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions." number 10 state, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.Number 12 states, "wear and/or deformation of articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Event Description

Patient's legal counsel reported patient underwent right shoulder reverse revision approximately 6 years post-implantation due to alleged pain and the fracture of the humeral tray taper resulting in disassociation of the humeral tray from the stem.All humeral components were removed and replaced.This report is based on allegations set forth in the plaintiff's complaint and the allegations contained therein are unverified.Operative notes revealed that the humeral tray taper had sheared off and remained engaged in the humeral stem and was cold-welded.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies were found.Root cause was associated with the design of the device.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The tray was returned for evaluation along with the bearing and the stem.The taper is fractured off of the tray, confirming the complaint.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

No further event information available at the time of this report.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5949555
• MDR Text Key: 54682679
• Report Number: 0001825034-2016-03614
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 697120
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR