FDA Adverse Event
Injury
Summary report: N
IDENTITY IMPRINT CR
MDR report key: 25165077
·
Received May 13, 2026
Report
- Report Number
- 3014833750-2026-00012
- Event Type
- Injury
- Date Received
- May 13, 2026
- Date of Event
- October 26, 2023
- Report Date
- May 13, 2026
- Manufacturer
- RESTOR3D, INC
- Product Code
- MBH
- UDI-DI
- M572TCR301T03S011
- PMA / PMN Number
- K230846
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE ORIGINAL REPORTER WAS CONSULTED FOR ADDITIONAL INFORMATION AND IT WAS DETERMINED TO BE A STANDARD TIBIAL ASEPTIC LOOSENING, WHICH IS A KNOWN FAILURE IN TOTAL KNEE REPLACEMENT. THERE IS INSUFFICIENT CLINICAL INFORMATION TO ESTABLISH A ROOT CAUSE OF THIS REVISION; ASEPTIC LOOSENING OCCURRENCE IS COMPARED TO RISK ASSESSMENT AND MONITORED.
Description of Event or Problem · 0
PATIENT RETURNED FOR REVISION KNEE SURGERY WITH A WELL-FIXED FEMORAL, WHILE TIBIAL IMPLANT EXPERIENCED ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607600 | IDENTITY IMPRINT CR | TOTAL KNEE REPLACEMENT | MBH | RESTOR3D, INC | TCR301T03S01 | 1404728 | M572TCR301T03S011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown | Required Intervention |