FDA.reportPublic FDA data

MAUDE MDR 2514231

MDR report key
2514231
Report number
0001825034-2012-00360
Event key
0
Event type
3
Date of event
2012-03-05
Date received
2012-04-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. ANGELA DICKSON
Address
56 E. BELL DRIVE WARSAW IN 46582 US
Phone
574-574-5743
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPREHENSIVE INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARDDEVICE, PROSTHESIS ALIGNMENTBIOMET ORTHOPEDICSIQON/A405940477810Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-0301. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6), 2012. DURING THE FINAL TRIAL REDUCTION PHASE, THE POST FRACTURED OFF THE TRIAL BEARING, AND HAD TO BE THE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY TO THE PROCEDURE, AND NO FOREIGN BODIES WERE RETAINED BY THE PATIENT.

N

Patient 1

THE PHYSICAL CONDITION OF THE TRIAL SUGGESTS INTERACTION WITH A SHARP SURGICAL INSTRUMENT AND THE FRACTURE OF THE DEVICE WAS CAUSED BY BENDING OVERLOAD. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.