FDA Adverse Event
Injury
Summary report: N
SWANSON
MDR report key: 8197587
·
Received December 26, 2018
Report
- Report Number
- 1043534-2018-00199
- Event Type
- Injury
- Date Received
- December 26, 2018
- Report Date
- December 4, 2018
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LITERATURE CITATION: CHUNG ET AL. A MULTICENTER CLINICAL TRIAL IN RHEUMATOID ARTHRITIS COMPARING SILICONE METACARPOPHALANGEAL JOINT ARTHROPLASTY WITH MEDICAL TREATMENT. JHS. 2009; VOLUME 34: PAGE(S) 815-823. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
ALLEGEDLY, IN A 2009 LITERATURE ARTICLE, BY CHUNG ET AL. TITLED A MULTICENTER CLINICAL TRIAL IN RHEUMATOID ARTHRITIS COMPARING SILICONE METACARPOPHALANGEAL JOINT ARTHROPLASTY WITH MEDICAL TREATMENT, THE AUTHORS MENTION 2 REVISIONS OF MCP ARTHROPLASTY WITH SWANSON FINGER IMPLANTS, ONE DUE TO RECURRENCE OF ULNAR DRIFT AND ANOTHER DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1035115 | SWANSON | PROSTHESIS, FINGER, POLYMER | KWF | WRIGHT MEDICAL TECHNOLOGY, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |