AEQUALIS REVERSED FRACTURE

MDR report key: 9636019 · Received January 28, 2020

Report

Report Number: 3000931034-2020-00003
Event Type: Injury
Date Received: January 28, 2020
Date of Event: December 31, 2019
Report Date: December 31, 2019
Product Code: KWS
PMA / PMN Number: K082120
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

Description of Event or Problem · 1

"FROM LITERATURE ""CONVERSION OF FAILED REVERSE TOTAL SHOULDER ARTHROPLASTY TO HEMIARTHROPLASTY: THREE CASES OF INSTABILITY AND THREE CASES OF GLENOID LOOSENING"" IN-SOO SONG ET AL., CLINICS IN ORTHOPEDIC SURGERY, 2019, 11:436-444. COMPLICATIONS WERE REPORTED IN 6 PATIENTS: 3 INSTABILITY AND 3 GLENOID LOOSENING."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
100926	AEQUALIS REVERSED FRACTURE	SHOULDER JOINT METAL PROSTHESIS	KWS

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other