FDA Adverse Event
Injury
Summary report: N
CARTIVA IMPLANT 10MM
MDR report key: 14084927
·
Received April 12, 2022
Report
- Report Number
- 3009351194-2022-00101
- Event Type
- Injury
- Date Received
- April 12, 2022
- Date of Event
- November 28, 2018
- Report Date
- October 31, 2024
- Manufacturer
- CARTIVA, INC
- Product Code
- PNW
- UDI-DI
- 00852897002038
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 0
THE INVESTIGATION OF THIS CASE HAS BEEN COMPLETED, AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD A 10MM IMPLANT IN THE FIRST METATARSAL OF HER RIGHT FOOT. THE IMPLANT HAS BEGUN TO MIGRATE INTO THE NEXT BONE. THE PATIENT STARTED NOTICING THIS ISSUE A YEAR AGO. PATIENT IS EXPERIENCING A LOT OF PAIN AND INFLAMMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD A 10MM IMPLANT IN THE FIRST METATARSAL OF HER RIGHT FOOT. THE IMPLANT HAS BEGUN TO MIGRATE INTO THE NEXT BONE. THE PATIENT STARTED NOTICING THIS ISSUE A YEAR AGO. PATIENT IS EXPERIENCING A LOT OF PAIN AND INFLAMMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145228 | CARTIVA IMPLANT 10MM | PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT | PNW | CARTIVA, INC | CAR-10-US | UNKNOWN | 00852897002038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention| O |