FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE PATELLA RESURFACING SIZE 2
MDR report key: 6511329
·
Received April 21, 2017
Report
- Report Number
- 3005180920-2017-00203
- Event Type
- Injury
- Date Received
- April 21, 2017
- Date of Event
- March 24, 2017
- Report Date
- April 21, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED ON 04 APRIL 2017 AND INCLUDES: THE PATIENT LACKED FLEXION. THE SURGEON REMOVED THE CEMENTED PATELLA AS WELL AS 3-4MM OF BONE. HE IMPLANTED A SIZE 3 PATELLA. HE PERFORMED A LATERAL RELEASE TO EASE SOFT TISSUE TENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEW PERFORMED ON 19 APRIL 2017. LOT 163383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2016. EXPIRATION DATE: 2021-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE KNEE IS LOOSE IN FLEXION. THE SURGEON PLANNED TO REVISE THE POLY ON (B)(6) 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293204 | GMK-SPHERE PATELLA RESURFACING SIZE 2 | PATELLA RESURFACING | JWH | MEDACTA INTERNATIONAL SA | 163383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |