FDA Adverse Event
Injury
Summary report: N
GII OVAL RESURFACING PAT 32MM
MDR report key: 7069542
·
Received November 29, 2017
Report
- Report Number
- 1020279-2017-01142
- Event Type
- Injury
- Date Received
- November 29, 2017
- Date of Event
- May 26, 2015
- Report Date
- February 22, 2018
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- UDI-DI
- 03596010485069
- PMA / PMN Number
- K951987
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OTHER COMPONENTS INVOLVED IN THIS EVENT, AS OUTLINED, HAVE BEEN COMMUNICATED THROUGH MDRS 1020279-2017-01140 , 1020279-2017-01141 AND 1020279-2017-01143 . (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATES THE PATIENT WAS READMITTED (B)(6) 2015 DUE TO MANIPULATION UNDER ANESTHESIA. THE PATIENT ALSO PRESENTED WITH SWELLING OF THE RIGHT KNEE ON (B)(6) 2016 HOWEVER NO TREATMENT WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO LOSS OF FLEXION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848460 | GII OVAL RESURFACING PAT 32MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED | JWH | SMITH & NEPHEW, INC. | 14LM02471 | 03596010485069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |