D
Patient 1
IT WAS REPORTED THAT, "KII WAS REVISED FOLLOWING COMPLICATIONS OF FRACTURE AND ASEPTIC LOOSENING. AWARENESS OCCURRED AS A RESULT OF REVIEWING THE DATA SET SUBMITTED AS PART OF A (B)(6)".
MAUDE MDR 1885676
- MDR report key
- 1885676
- Report number
- 9610726-2010-00383
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-10-06
- Date received
- 2010-10-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- RITA INTORELLA
- Address
- 325 CORPORATE DRIVE MAHWAH NJ 07430 US
- Phone
- 201-201-2018
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | KINEMATIC II | IMPLANT | STRYKER ORTHOPAEDICS LIMERICK | LGE | NA | UNK | UNK | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-10-25 | 0 | 1. R |
Event Narratives#
N
Patient 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.