MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ORTHOSIZE DIGITAL TMP SOFTWARE

Model Number N/A

Device Problem Computer Software Problem (1112)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided.Date of event - ni, device product code - ni, manufacture date ¿ ni.There are warnings in the package insert that state that this type of event can occur.Under warnings, number 3 states, "a trained medical professional determines final implant type and size intraoperatively." number 4 states, "orthosize software does not determine the final size and type of hardware to be implanted.".

Event Description

It was reported that femoral stem templates made by the software were smaller than expected and there have been reports of femoral subsidence post-operatively.The number of events are unknown and no revision procedures have been reported to date.

• Brand Name: ORTHOSIZE DIGITAL TMP SOFTWARE
• Type of Device: SOFTWARE
• 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: 5813397
• MDR Text Key: 50140045
• Report Number: 0001825034-2016-02683
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• 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: 9999997
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other