ORTHOSIZE DIGITAL TMP SOFTWARE N/A 9999997

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-29 for ORTHOSIZE DIGITAL TMP SOFTWARE N/A 9999997 manufactured by Biomet Orthopedics.

Event Text Entries

[34646610] 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. "
Patient Sequence No: 1, Text Type: N, H10


[34646611] 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.
Patient Sequence No: 1, Text Type: D, B5


[36865010] This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10


[36865011] 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 14 stem was implanted.
Patient Sequence No: 1, Text Type: D, B5


[44041163] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2015-05213
MDR Report Key5333026
Report SourceCOMPANY REPRESENTATIVE
Date Received2015-12-29
Date of Report2016-04-28
Date of Event2015-12-01
Date Mfgr Received2016-04-28
Date Added to Maude2015-12-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MEGAN HAAS
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5743726700
Manufacturer G1BIOMET ORTHOPEDICS
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameORTHOSIZE DIGITAL TMP SOFTWARE
Generic NameSOFTWARE
Product CodeOSN
Date Received2015-12-29
Model NumberN/A
Catalog Number9999997
Lot NumberV1.2.6
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-12-29

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