G7 STR MODULAR SHELL INSERTER N/A 110003451

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-11 for G7 STR MODULAR SHELL INSERTER N/A 110003451 manufactured by Biomet Orthopedics.

Event Text Entries

[26075905] Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03949).
Patient Sequence No: 1, Text Type: N, H10


[26075906] It was reported that a patient underwent an initial hip arthroplasty on (b)(6) 2015. During the procedure, the cup inserter became marred upon impaction and the inner lock bolt became captured inside the handle. The entry hole was also disfigured and the inner bolt could not pass freely. The distal thread also became deformed due to impaction. The inner poly was seated by impaction. The inserter was used to complete the procedure. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


[28844596] 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


[31696170] This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Based on device history records, the product was made to print and correct materials. He threaded inserter shaft cannot be inserted into the through hole of the handle body due to the damage. Instrument likely failed due to excessive impacts to the strike plate, which deformed material around through hole.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2015-03948
MDR Report Key5070259
Date Received2015-09-11
Date of Report2015-11-18
Date of Event2015-08-19
Date Mfgr Received2015-11-18
Device Manufacturer Date2015-01-19
Date Added to Maude2015-09-11
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 NameG7 STR MODULAR SHELL INSERTER
Generic NamePROSTHESIS, HIP
Product CodeLKD
Date Received2015-09-11
Returned To Mfg2015-09-30
Model NumberN/A
Catalog Number110003451
Lot Number998290
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2015-09-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.