FDA Adverse Event
Malfunction
Summary report: N
R3 OFFSET IMPACTOR TIP
MDR report key: 16807788
·
Received April 25, 2023
Report
- Report Number
- 1020279-2023-00920
- Event Type
- Malfunction
- Date Received
- April 25, 2023
- Date of Event
- April 3, 2023
- Report Date
- July 28, 2023
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRY
- UDI-DI
- 03596010599391
- PMA / PMN Number
- K121393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H11: THIS COMPLAINT HAS BEEN REASSESSED BASED ON ADDITIONAL INFORMATION GATHERED BY THE MANUFACTURER. IT WAS DETERMINED THAT THIS EVENT IS A DUPLICATE OF THE SAME EVENT REPORTED UNDER 1020279-2023-00919 (INTERNAL COMPLAINT REFERENCE: (B)(4)). SMITH AND NEPHEW CONSIDERS (B)(4) (CURRENT MDR REPORT) AS CLOSED. THE INVESTIGATION RESULTS FOR THIS EVENT HAVE BEEN ALREADY DISCLOSED UNDER MDR REPORT 1020279-2023-00919.
Additional Manufacturer Narrative · 0
INTERNAL COMPLAINT REFERENCE: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) R3 OFFSET IMPACTOR TIP BROKE WHILE INSERTING THE CUP INTO THE PATIENTS ACETABULUM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491629 | R3 OFFSET IMPACTOR TIP | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | HRY | SMITH & NEPHEW, INC. | 71363077 | UNKNOWN | 03596010599391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |