N
Patient 1
AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.
MAUDE MDR 9817390
- MDR report key
- 9817390
- Report number
- 3004105610-2020-00058
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-18
- Date received
- 2020-03-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. DIANA ROGERS
- Address
- 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE BOREHAMWOOD WD6 3 GB
- Phone
- 208-208-2082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | METS DISTAL FEMUR - FEMORAL COMPONENT | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | STANMORE IMPLANTS WORLDWIDE | KRO | UNK_STM | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-11 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT HAS BEEN REPORTED THAT "DISENGAGEMENT ON A DISTAL FEMUR + PROXIMAL TIBIA ON A SURGERY DONE ON (B)(6) 2019. IT WAS FURTHER REPORTED: THE DISASSOCIATION IS BETWEEN THE FEMORAL COMPONENT AND THE INTEGRAL SHAFT&STEM.