MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ORTHOSIZE DIGITAL TMP SOFTWARE

Model Number N/A

Device Problems Fitting Problem (2183); Computer Operating System Problem (2898)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.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

It was reported that during an initial total hip arthroplasty procedure on an unknown date the orthosize v1.2.6 software did not correctly template the stem.The surgeon broached and attempted to implant the stem, but it did not fit.The stem was removed and the surgeon continuously broached until the appropriate size was reached.

Manufacturer Narrative

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

Event Description

It was reported that during an initial total hip arthroplasty procedure on (b)(6), 2015 the orthosize v1.2.6 software templated a size 8 stem.The surgeon broached to size 8 and attempted to implant the stem; however it did not fit.The stem was removed and the surgeon continuously broached until the appropriate size was reached.A size 12 stem was implanted.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Evaluation of software found no evidence of product non-conformance.Digital implant image comparison testing was conducted and all images were accurate.A conclusive root cause of the event could not be determined.

• 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: 5341146
• MDR Text Key: 34957914
• Report Number: 0001825034-2016-00017
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention