FDA Adverse Event
Injury
Summary report: N
ARCHER R1 REVERSE SHOULDER SYSTEM
MDR report key: 15323366
·
Received August 30, 2022
Report
- Report Number
- 3012552981-2022-00020
- Event Type
- Injury
- Date Received
- August 30, 2022
- Date of Event
- August 18, 2022
- Report Date
- August 30, 2022
- Manufacturer
- CATALYST ORTHOSCIENCE INC
- Product Code
- PHX
- UDI-DI
- 00811596030452
- 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 36 +4, 1230-7504-002, LOT # 2105614. 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 EXPERIENCED A FALL THAT MAY HAE CAUSED A DISSOCIATION. THE PATIENT UNDERWENT REVISION 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 |
|---|---|---|---|---|---|---|---|
| 147798 | ARCHER R1 REVERSE SHOULDER SYSTEM | SHOULDER PROSTHESIS | PHX | CATALYST ORTHOSCIENCE INC | 1230-7504-002 | 2105614 | 00811596030452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 1230-7504-002, LOT 2105614 |