D
Patient 1
DEVICE WAS REMOVED FROM PATIENT AS IT WAS "ERODING THROUGH THE SKIN". THE SURGEON NOTED THAT THE EROSION WAS NOT CAUSED BY OPERATIVE TECH OR IMPLANTS, BUT POSSIBLE FURTHER DEGENERATIVE RHEUMATOID ARTHRITIS.
MAUDE MDR 1023641
- MDR report key
- 1023641
- Report number
- 1651501-2008-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-01-23
- Date received
- 2008-03-31
- 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
- LYNN FERGUSON
- Address
- 8700 CAMERON ROAD STE. 100 AUSTIN TX 78754 US
- Phone
- 512-512-5128
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | TOTAL FINGER JOINT IMPLANT | ASCENSION ORTHOPEDICS, INC. | KWF | PIP-200 | PIP-200-10P | 06-1220 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-03-31 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE IMPLANT COMPONENTS SATISFIED ALL APPLICABLE MANUFACTURING SPECIFICATIONS. THE IMPLANTS DID NOT DISPLAY ANY EVIDENCE OF DAMAGE DUE TO FUNCTION OVER THE APPROXIMATELY ONE YEAR DURATION IMPLANT DURATION. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DISTAL IMPLANT SURFACE CHIPS HAD EXISTED FOR A SIGNIFICANT PERIOD OF TIME.