FDA Adverse Event Injury Summary report: N

UNKNOWN ZIMMER SHOULDER GLENOID

MDR report key: 5074496 · Received September 14, 2015

Report

Report Number: 1822565-2015-01867
Event Type: Injury
Date Received: September 14, 2015
Report Date: August 20, 2015
Manufacturer: ZIMMER INC
Product Code: KWR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S1058274613006423. (B)(4). OPERATIVE NOTES WERE REQUESTED HOWEVER NONE PROVIDED. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. THE PART AND LOT NUMBERS OF THE PRODUCT ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE PRODUCT WAS USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THIS PRODUCT COULD NOT BE REVIEWED DUE TO THE LACK OF LOT NUMBERS. IT COULD NOT BE CONFIRMED IF THE DEVICES USED ARE AN APPROVED AND COMPATIBLE COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT HAS BEEN REPORTED THAT 3 SHOULDERS DEMONSTRATED MILD LUCENCIES OF THE GLENOID COMPONENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
606729	UNKNOWN ZIMMER SHOULDER GLENOID	SHOULDER PROSTHESIS	KWR	ZIMMER INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other