MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,07 report with the FDA on 2012-12-28 for SWANSON FINGER JOINT manufactured by Wright Medical Technology, Inc..
[3059891]
Allegedly, per iordache sd, daneman n, axelrod ts. 18. Hand (n y). 2009 jun;4(2):129-33. Epub 2008 oct 9. "mycobacterium chelonae infection following silicone arthroplasty of the metacarpophalangeal joints: a case report. " (b)(4). Upper limb surgery, (b)(6). "we present a case of infection caused by an uncommon pathogen, mycobacterium chelonae, in a patient that underwent swanson silicone arthroplasty of the metacarpophalangeal joints for rheumatoid arthritis. This is the first report of an infection caused by nontuberculous mycobacteria in flexible silicone implants in the hand. The patient was successfully treated with implant removal, debridement, and antimicrobials tailored to the results of in vitro susceptibility testing. "
Patient Sequence No: 1, Text Type: D, B5
[10498094]
Investigation is not complete. Trends will be evaluated. The event code is addressed in the package insert. This report will be updated when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[15418659]
Conclusion: no device failure. The complaint was reviewed; however, the product was not returned. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2012-01727 |
| MDR Report Key | 2888843 |
| Report Source | 03,07 |
| Date Received | 2012-12-28 |
| Date of Report | 2012-11-28 |
| Date Mfgr Received | 2013-03-15 |
| Date Added to Maude | 2012-12-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 901867-414 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWANSON FINGER JOINT |
| Generic Name | SMALL JOINT COMPONENT, CODE:KWH |
| Product Code | KWF |
| Date Received | 2012-12-28 |
| Lot Number | NI |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-28 |