FDA Adverse Event Injury Summary report: N

UNKNOWN COONRAD/MORREY HUMERAL COMPONENT

MDR report key: 6129197 · Received November 28, 2016

Report

Report Number: 0001822565-2016-04295
Event Type: Injury
Date Received: November 28, 2016
Report Date: November 20, 2016
Manufacturer: ZIMMER, INC.
Product Code: JDB
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. AGE OR DATE OF BIRTH - NI, WEIGHT - NI, DATE OF DEATH - NI, EXPIRATION DATE - NA, DATE IMPLANTED - NA, DATE EXPLANTED ¿ NA, MANUFACTURE DATE - NA.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED SINCE THE LOT NUMBER IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT EXPERIENCED LOOSENING OF THE HUMERAL COMPONENT FOLLOWING ELBOW ARTHROPLASTY. NO REVISION HAS BEEN REPORTED TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
779998	UNKNOWN COONRAD/MORREY HUMERAL COMPONENT	ELBOW PROSTHESIS	JDB	ZIMMER, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention