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

Model Number N/A

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/25/2016

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.There are warnings in the package insert that this type of event can occur.Under possible adverse effects, number 10 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." requested but not returned by hospital.

Event Description

Patient underwent a shoulder revision approximately five months post-implantation; during the revision it was noted that the humeral tray had fractured at the taper adapter.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Per the revision op notes, the humeral component was found to be worn and stress fractured over time because it appeared to be very smooth.It took about 3.5 hours for the surgeon to remove the trunnion from the stem.Review of device history records found these units were released to distribution with no related deviations or anomalies.Root cause was unable to be determined with the information 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

Patient underwent a reverse total shoulder revision approximately four (4) years post-implantation.During the revision, it was noted that the humeral tray had fractured at the taper adapter.It was also noted that the component had worn and stress fractured over time.No further information is available at this time.

• 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: 5792071
• MDR Text Key: 49461993
• Report Number: 0001825034-2016-02568
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 981150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: 06/27/2018; 09/10/2018
• Supplement Dates FDA Received: 08/13/2018; 10/03/2018
• 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: 60 YR