FDA Adverse Event
Injury
Summary report: N
ARCHER R1 REVERSE SHOULDER SYSTEM
MDR report key: 14074918
·
Received April 11, 2022
Report
- Report Number
- 3012552981-2022-00010
- Event Type
- Injury
- Date Received
- April 11, 2022
- Date of Event
- March 16, 2022
- Report Date
- April 11, 2022
- Manufacturer
- CATALYST ORTHOSCIENCE INC
- Product Code
- PHX
- UDI-DI
- 00811596030490
- PMA / PMN Number
- K202611
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CONCOMITANT PRODUCT: POLY INSERT IMPLANT SIZE 40 +4, 1230-7505-002, LOT # 2105623. 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 WAS PLAYING BASKETBALL AND HAD HIS ARM IN EXTREME ABDUCTION WHEN HE FELT A POP IN HIS SHOULDER. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE HUMERAL INSERT AND HUMERAL STEM WITH ANOTHER MANUFACTURER'S DEVICE APPROXIMATELY 05 MONTHS AFTER THE PREVIOUS SURGERY. THE HUMERAL INSERT WAS FOUND TO BE DISSOCIATED FROM THE HUMERAL STEM. CUSTOMER HAS INDICATED THAT THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1441261 | ARCHER R1 REVERSE SHOULDER SYSTEM | SHOULDER PROSTHESIS | PHX | CATALYST ORTHOSCIENCE INC | 1230-7505-002 | 2105623 | 00811596030490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | 1230-7505-002, LOT # 2105623 |