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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 01/12/2015

Event Type  Injury  

Event Description

It was reported that patient underwent right total shoulder arthroplasty on an unknown date.Subsequently, the patient underwent seven revisions on unknown dates for unknown reasons.Recently, the patient experienced a traumatic fall, resulting in a fractured reverse morse taper.No revision has been reported to date.

Event Description

It was reported that patient underwent right total shoulder arthroplasty on an unknown date.Subsequently, the patient underwent seven revisions on unknown dates for unknown reasons.Recently, the patient experienced a traumatic fall, resulting in a fractured reverse morse taper that had been implanted (b)(6) 2011.Subsequently, patient underwent a revision procedure (b)(6) 2015.

Manufacturer Narrative

The product identification necessary to review history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Catalog number, lot number and expiration date - unknown.Date implanted - unknown.Initial reporter phone number: (b)(6).510k number - unknown.Manufacture date ¿ unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Manufacturer Narrative

This follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to report device evaluation results.Product was returned for evaluation on february 16, 2015.Dimensional evaluation of the device was not performed due to the nature of the complaint and because it fractured at the taper joint.The distortion of the base and the embedded taper also make measurements meaningless as the fracture occurred due to loading issues and not dimensional ones.Based on device history records review, the product was made to print and correct materials and product left conforming to print as there was no evidence that states otherwise.The root cause is likely to be biomechanical overload leading to the possibility of an overstressed joint when the patient fell as mentioned in the complaint.Thus the conditions of use caused or contributed to this event.

• 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: 4357868
• MDR Text Key: 5203228
• Report Number: 0001825034-2014-09245
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 697190
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2015; 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• 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