MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ORTHOSIZE DIGITAL TMP SOFTWARE

Model Number N/A

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Evaluation of software found no evidence of product non-conformance.Digital implant image comparison testing was conducted and all images were accurate.Analysis of patient x-rays found the incorrect protocol was used, resulting in the incorrect template sizes.There are warnings in the package insert that state that this type of event can occur: "a trained medical professional determines final implant type and size intraoperatively." "orthosize software does not determine the final size and type of hardware to be implanted.".

Event Description

During a total hip arthroplasty, it was discovered the orthosize v1.2.6 software templated a size 14 stem for the patient's left hip and a size 11 stem for the patient's right hip.The surgeon broached to the appropriate size and implanted a size 16 stem in the patient's left hip and a size 16 stem in the patient's right hip.There was no patient injury or delay in procedure.

• 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: 5683645
• MDR Text Key: 46276092
• Report Number: 0001825034-2016-01767
• Device Sequence Number: 0
• Product Code: LLZ
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 9999997
• Device Lot Number: V1.2.6
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 55 YR