FDA Adverse Event
Injury
Summary report: N
AEQUALIS REVERSED FRACTURE
MDR report key: 9641129
·
Received January 29, 2020
Report
- Report Number
- 3000931034-2020-00015
- Event Type
- Injury
- Date Received
- January 29, 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 "REVERSE TOTAL SHOULDER ARTHROPLASTY: SALVAGE PROCEDURE FOR FAILED PRIOR ARTHROPLASTY" SEONG HWAN JO ET AL., CLINICS IN ORTHOPEDIC SURGERY, 2017, 9:200-206. THE AEQUALIS SYSTEM WAS USED IN 3 OF 7 PATIENTS, AND BIOMET AND AEQUALIS SYSTEMS WERE USED FOR THE GLENOID AND HUMERAL COMPONENTS RESPECTIVELY IN 1 PATIENT. THE CAUSE OF REVISION SURGERY WAS INFECTION IN 2 PATIENTS, HUMERAL STEM LOOSENING IN 2 PATIENTS, GLENOID ARTHROPATHY IN 2 PATIENTS AND GLENOID LOOSENING IN 1 PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104891 | AEQUALIS REVERSED FRACTURE | SHOULDER JOINT METAL PROSTHESIS | KWS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |