FDA.reportPublic FDA data

MAUDE MDR 5033051

MDR report key
5033051
Report number
1822565-2015-01596
Event key
0
Event type
3
Date of event
2003-10-01
Date received
2015-08-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KEVIN ESCAPULE
Address
P.O. BOX 708 WARSAW IN 46581 US
Phone
800-800-8006
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN ZIMMER B/F HUMERAL STEMSHOULDER PROSTHESISZIMMER INCKWRR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-2601. O

Event Narratives#

N

Patient 1

(B)(4). OTHER DEVICES USED: CATALOG #UNK, UNKNOWN ZIMMER B/F HUMERAL HEAD, LOT #UNK; CATALOG #UNK, UNKNOWN ZIMMER B/F GLENOID, LOT #UNK. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

D

Patient 1

IT IS REPORTED THE PATIENT FELL ON THEIR OPERATIVE ARM WHILE TRYING TO TAKE THE BUMPER OFF OF HIS CAR.

N

Patient 1

THE PROVIDED OPERATIVE NOTES ARE VAGUE, AS SUCH; NO DEFINITIVE STATEMENTS CAN BE MADE REGARDING THE SURGICAL TECHNIQUE. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE PART AND LOT NUMBERS OF THE PRODUCT ARE UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THESE PRODUCTS WERE USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THESE PRODUCTS COULD NOT BE REVIEWED DUE TO THE LACK OF LOT NUMBERS. IT COULD NOT BE CONFIRMED IF THE DEVICES ARE AN APPROVED AND COMPATIBLE COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.