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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 07/06/2016

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.There are warnings in the package insert that state 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." this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2016-02997 / 02998).

Event Description

Patient was revised approximately five years post-implantation due to a fractured trunnion.The humeral stem, polyethylene bearing, and humeral tray were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of manufacturing history found no evidence of product non-conformance.Visual examination of the tray confirms that the humeral tray taper is indeed fractured off of the tray.Visual inspection of the stem confirms that the humeral tray taper is still stuck in the stem.The humeral tray taper appears to have been cold welded to the stem.The junction of the humeral tray taper and stem was damaged likely upon attempted removal of the humeral tray taper, making further evaluation impossible.Therefore, the root cause cannot be determined.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant products: biomet comprehensive stem, catalog #: 113635, lot: unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The tray, stem, and bearing were received for evaluation.Visual inspection of the tray confirms that the humeral tray taper is fractured off the tray.The humeral tray taper appears to have been cold welded to the stem.The junction of the humeral tray taper and stem was damaged likely upon attempted removal of the humeral tray taper with a midas rex or similar instrument making further evaluation impossible.This device is used for treatment.Evaluation of the reported event confirmed that previous corrective action has been implemented for this reported issue, and that this product was manufactured prior to that corrective action.The root cause was determined to be related to design.

• 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
• 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: 5851870
• MDR Text Key: 51338242
• Report Number: 0001825034-2016-02998
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 424640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2011
• 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