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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ORTHOSIZE DIGITAL TMP SOFTWARE

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BIOMET ORTHOPEDICS ORTHOSIZE DIGITAL TMP SOFTWARE Back to Search Results
Model Number N/A
Device Problems Fitting Problem; Computer Operating System Problem
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.

 
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Brand NameORTHOSIZE DIGITAL TMP SOFTWARE
Type of DeviceSOFTWARE
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 Key5341146
Report Number0001825034-2016-00017
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
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 Received01/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number9999997
Device LOT NumberV1.2.6
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2016
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 Unkown
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 01/04/2016 Patient Sequence Number: 1
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