HYBRID GLENOID TRIAL PS 4MM LARGE N/A 406194

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-05-17 for HYBRID GLENOID TRIAL PS 4MM LARGE N/A 406194 manufactured by Biomet Orthopedics.

Event Text Entries

[1501473] Patient underwent a shoulder procedure on (b) (6) 2010. The surgeon placed a trial glenoid inside the patient to gauge the size of glenoid implant required. Upon removal, one of the pegs from the glenoid trial was still in the prepared hole. Unintentionally, the peg was eventually pushed further into the prepared hole and lost behind the patient? S glenoid. The surgeon was unable to remove the peg, and as a result, the patient retained a foreign body.
Patient Sequence No: 1, Text Type: D, B5


[8657261] Review of device history records show that lot released with no recorded anomaly or deviation. Evaluation of the returned component found some scratches and notches around the edge of the proximal rim. There were also scratches and gouges on the articulating surface and scratches on the perimeter edges. The fracture surface has ratchet marks along both side edges that suggest a fatigue fracture. (b) (4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1825034-2010-00173
MDR Report Key1691420
Report Source07
Date Received2010-05-17
Date of Report2010-04-22
Date of Event2010-04-22
Date Facility Aware2010-05-04
Date Mfgr Received2010-04-22
Device Manufacturer Date2007-11-12
Date Added to Maude2010-05-17
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 FDA0
Event Location3
Manufacturer ContactMRS. MIRANDA PARCELS
Manufacturer Street56 EAST BELL DRIVE P.O. BOX 587
Manufacturer CityWARSAW IN 465810587
Manufacturer CountryUS
Manufacturer Postal465810587
Manufacturer Phone5742676639
Manufacturer G1BIOMET ORTHOPEDICS
Manufacturer Street56 EAST BELL DRIVE P.O. BOX 587
Manufacturer CityWARSAW IN 46581058
Manufacturer CountryUS
Manufacturer Postal Code46581 0587
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYBRID GLENOID TRIAL PS 4MM LARGE
Generic NamePROSTHESIS, ALIGNMENT
Product CodeIQO
Date Received2010-05-17
Returned To Mfg2010-04-23
Model NumberN/A
Catalog Number406194
Lot Number161900
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device Age2 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2010-05-17

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