FDA Adverse Event Injury Summary report: N

UNKNOWN ZIMMER BIGLIANI/FLATOW HUMERAL STEM

MDR report key: 5014325 · Received August 19, 2015

Report

Report Number: 1822565-2015-01519
Event Type: Injury
Date Received: August 19, 2015
Report Date: July 29, 2015
Manufacturer: ZIMMER INC
Product Code: KWR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

OTHER DEVICES USED: CATALOG #UNK, UNKNOWN STANDARD PEGGED WHITE BIGLIANI/FLATOW GLENOID, LOT #UNK, CATALOG #UNK, UNKNOWN 46 MM BIGLIANI/FLATOW HUMEAL HEAD, LOT #UNK. 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.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT HAD EXPERIENCED DEEP VEIN THROMBOSIS, RESULTING IN A PULMONARY EMBOLISM AND SHORTNESS OF BREATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
548088	UNKNOWN ZIMMER BIGLIANI/FLATOW HUMERAL STEM	KWR	KWR	ZIMMER INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other