FDA Adverse Event
Injury
Summary report: N
MCK TIBIAL BASEPLATE-LM/RL-SZ 7
MDR report key: 24678566
·
Received March 24, 2026
Report
- Report Number
- 0002249697-2026-00229
- Event Type
- Injury
- Date Received
- March 24, 2026
- Date of Event
- February 25, 2026
- Report Date
- March 23, 2026
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- HRY
- UDI-DI
- 00848486000738
- PMA / PMN Number
- K242831
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE FOLLOWING INFORMATION WAS PROVIDED: RESTORIS TIBIAL PROSTHESIS, 180607 #26090721, REVISED TO TKA - IMPLANT FOUND FRACTURED IN SITU, IMPLANT IN SITU APPROX 4 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740137 | MCK TIBIAL BASEPLATE-LM/RL-SZ 7 | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | HRY | MAKO SURGICAL CORP. | 26090721 | 00848486000738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |