FDA Adverse Event
Injury
Summary report: N
CARTIVA
MDR report key: 13606353
·
Received February 25, 2022
Report
- Report Number
- 3009351194-2022-00030
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- October 24, 2018
- Report Date
- January 15, 2021
- Manufacturer
- CARTIVA
- Product Code
- PNW
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT WAS NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. ON NOVEMBER 10TH, 2020 STRYKER TRAUMA AND EXTREMITIES ACQUIRED CARTIVA, WRIGHT MEDICAL, TORNIER INC. AND TORNIER SAS. AN EFFORT WAS MADE TO ALIGN THE ACQUIRED ENTITY COMPLAINT FILES WITH STRYKER'S POLICIES AND PROCEDURES. STRYKER HAS PERFORMED RETROSPECTIVE REVIEW OF COMPLAINTS AND THE REPORTABILITY DECISION WAS REVISED TO REPORT THIS INCIDENT UNDER THE MDR/VIGILANCE PROCESS.
Description of Event or Problem · 0
FDA MEDWATCH REPORT RECEIVED WHERE AN UN-IDENTIFIED PATIENT ALLEGED RECEIVING A CARTIVA IMPLANT ON (B)(6) 2017 AND FEELING CONTINUED PAIN ALONG WITH SUBSIDENCE AND LOSS OF JOINT SPACE APPROXIMATELY 4 WEEKS AFTER IMPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358249 | CARTIVA | PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT | PNW | CARTIVA | CARTIVA SCI | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Disability| O |