FDA Adverse Event
Injury
Summary report: N
ITOTAL
MDR report key: 3041985
·
Received April 1, 2013
Report
- Report Number
- 3004153240-2013-00059
- Event Type
- Injury
- Date Received
- April 1, 2013
- Report Date
- March 5, 2013
- Manufacturer
- CONFORMIS, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT AND DEVICE IDENTIFICATION INFORMATION IS UNKNOWN. NO INVESTIGATION CAN BE CONDUCTED.
Description of Event or Problem · 1
THE HUSBAND OF A CONFORMIS PATIENT INDICATED IN AN ONLINE FORUM POST THAT HIS WIFE HAD A CONFORMIS TOTAL KNEE REPLACEMENT APPROXIMATELY THREE MONTHS AGO. PHYSICAL THERAPY CAUSED KNEE CAP TO DISLOCATE AND CAUSED PAIN FOR THE PATIENT. THE SURGEON INDICATED TO THE PATIENT THAT REVISION SURGERY MAY BE REQUIRED IF PHYSICAL THERAPY DOES NOT RESOLVE THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131368 | ITOTAL | TOTAL KNEE REPLACEMENT SYSTEM | JWH | CONFORMIS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |