FDA Adverse Event
Injury
Summary report: N
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 10 MM
MDR report key: 10395852
·
Received August 12, 2020
Report
- Report Number
- 0002249697-2020-01649
- Event Type
- Injury
- Date Received
- August 12, 2020
- Date of Event
- July 24, 2020
- Report Date
- August 12, 2020
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- NPJ
- UDI-DI
- 00848486016562
- PMA / PMN Number
- K150307
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 4; 180514; 1W6Y-1. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; 180615; 26320719-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.
Description of Event or Problem · 1
DR. PERFORMED AN I&D AND INSERT SWAP ON THE RIGHT MEDIAL MAKO UNI DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 859480 | MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 10 MM | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM | NPJ | STRYKER ORTHOPAEDICS-MAHWAH | 180735-3 | XL62NY | 00848486016562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |