FDA Adverse Event
Injury
Summary report: N
ARCHER R1 REVERSE SHOULDER SYSTEM
MDR report key: 13722515
·
Received March 10, 2022
Report
- Report Number
- 3012552981-2022-00005
- Event Type
- Injury
- Date Received
- March 10, 2022
- Date of Event
- February 8, 2022
- Report Date
- February 24, 2022
- Manufacturer
- CATALYST ORTHOSCIENCE INC
- Product Code
- PHX
- UDI-DI
- 00811596030469
- PMA / PMN Number
- K202611
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CONCOMITANT PRODUCT: POLY INSERT IMPLANT SIZE 36 +8, 1230-7504-003, LOT # 2105615. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE INVESTIGATION IS ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD USED THEIR ARM TO PUSH THEMSELVES UP AND OUT OF BED IN AN AWKWARD MANNER APPROXIMATELY 02 MONTHS FOLLOWING PREVIOUS SHOULDER ARTHROPLASTY. THE SURGEON REPORTED THAT THE HUMERAL INSERT WAS DISASSOCIATED FROM THE HUMERAL STEM. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE HUMERAL INSERT WITH AN EQUIVALENT SIZE HUMERAL INSERT. THE IMPLANT HAS BEEN RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1622873 | ARCHER R1 REVERSE SHOULDER SYSTEM | SHOULDER PROSTHESIS | PHX | CATALYST ORTHOSCIENCE INC | 1230-7504-003 | 2105615 | 00811596030469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 1230-7504-003, LOT # 2105615 |