N
Patient 1
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THESE DOCUMENTS AS SOON AS IT BECOMES AVAILABLE.
MAUDE MDR 9860733
- MDR report key
- 9860733
- Report number
- 1644408-2020-00244
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-21
- Date received
- 2020-03-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- TEFFANY HUTTO
- Address
- 9800 METRIC BLVD AUSTIN, TX 78758-5445, US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RSP | RSP HUM SOCKET INSERT, 36MM +4MM, STANDARD | ENCORE MEDICAL L.P. | PHX | 508-00-436 | 508-00-436 | 919F1910 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 | 1. R |
Event Narratives#
D
Patient 1
REVISION SURGERY - PATIENT PRESENTED TO SURGEON WITH PAIN IN THE LEFT SHOULDER. UPON FURTHER TESTS AND WORK-UPS, IT WAS PROBABILITY THE PATIENT'S LEFT SHOULDER WAS INFECTED. THEN SURGEON EXTRACTED THE ABOVE NOTATED IMPLANTS IN A SURGICAL PROCEDURE AT THE UNIVERSITY OF COLORADO HOSPITAL.