FDA Adverse Event
Other
Summary report: N
ASCENSION MCP
MDR report key: 1304789
·
Received February 3, 2009
Report
- Report Number
- 1651501-2009-00005
- Event Type
- Other
- Date Received
- February 3, 2009
- Date of Event
- January 19, 2009
- Report Date
- February 3, 2009
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MCP JOINT REVISION WAS PERFORMED ON (B)(6) 2009. SURGEON NOTED ON ORIGINAL SURGERY THAT THE COLLATERAL LIGAMENTS WERE "TOO TIGHT" AND THIS LIKELY CAUSED THE JOINT TO SUBLUX. UPON REMOVAL, IT WAS NOTED THAT BOTH PROXIMAL AND DISTAL COMPONENTS SHOWED SOME EROSION AND WEAR. A SMALL FRAGMENT FRACTURED OFF THE PROXIMAL HEAD. THE JOINT WAS REPLACED WITH A SILICONE MCP. THE SURGEON DID NOT FAULT THE IMPLANTS; HE FELT THAT THE TIGHTNESS OF THE LIGAMENTS CAUSED THE ISSUE. DEVICES ARE AVAILABLE FOR RETURN, BUT HAVE NOT YET BEEN RELEASED FROM HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION MCP | TOTAL FINGER JOINT IMPLANT | KYJ | ASCENSION ORTHOPEDICS, INC. | MCP-100 (DISTAL) | 08-0670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |