FDA Adverse Event
Injury
Summary report: N
EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT
MDR report key: 18013499
·
Received October 26, 2023
Report
- Report Number
- 3010536692-2023-00197
- Event Type
- Injury
- Date Received
- October 26, 2023
- Report Date
- January 2, 2024
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HRY
- UDI-DI
- M684EIS4S12L1
- PMA / PMN Number
- K093552
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 0
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2016 AND L TKR, DATE UNKNOWN, WITH BOTH PATELLAE PRESERVED. BOTH KNEES WERE REVISED ON (B)(6) 2023 DUE TO PATELLA PAIN. PATELLAE ADDED AND INSERTS WERE REPLACED EVEN THOUGH THE IN-SITU ONES WERE IN PRISTINE CONDITION. LEFT KNEE. SURGICAL SPECIALTIES REF (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674632 | EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT | KNEE COMPONENT | HRY | MICROPORT ORTHOPEDICS INC. | EIS4S12L | UNKNOWN | M684EIS4S12L1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Required Intervention |