FDA Adverse Event
Injury
Summary report: N
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM
MDR report key: 11551855
·
Received March 23, 2021
Report
- Report Number
- 0002249697-2021-00505
- Event Type
- Injury
- Date Received
- March 23, 2021
- Date of Event
- February 24, 2021
- Report Date
- March 23, 2021
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- NPJ
- UDI-DI
- 00848486016647
- PMA / PMN Number
- K150307
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 7; CAT # 180517; LOT # 567017-M MCK TIBIAL BASEPLATE-RM/LL-SZ 7; CAT # 180617; LOT # 26121118-01 SIMPLEX HV US 1 PACK; CAT # 6194-1-001; LOT # 925AB939EA IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REPORTED EVENT AN EVENT REGARDING INFECTION INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT MAKO PKA DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE PRIMARY IMLANT SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 453612 | MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM | NPJ | STRYKER ORTHOPAEDICS-MAHWAH | 180737-1 | 608YJ0 | 00848486016647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |