FDA Adverse Event
Malfunction
Summary report: N
METS MODULAR DISTAL FEMUR IMPLANT
MDR report key: 4373104
·
Received December 24, 2014
Report
- Report Number
- 3004105610-2014-00214
- Event Type
- Malfunction
- Date Received
- December 24, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- STANMORE IMPLANTS WORLDWIDE LTD.
- Product Code
- KRO
- PMA / PMN Number
- K120992
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. AS THE INVESTIGATION IS ONGOING IT IS NOT POSSIBLE TO COMMENT ON THE ROOT CAUSE OF THE REPORTED FRACTURE AT THIS TIME. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).
Description of Event or Problem · 1
IT WAS REPORTED BY THE SURGEON THAT A REVISION PROCEDURE WAS REQUIRED DUE TO A BROKEN IMPLANT BETWEEN THE STEM AND SHAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851640 | METS MODULAR DISTAL FEMUR IMPLANT | DISTAL FEMUR IMPLANT | KRO | STANMORE IMPLANTS WORLDWIDE LTD. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |