MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2013-09-13 for SWANSON FINGER JOINT IMPLANT manufactured by Wright Medical Technology, Inc..
[3806525]
Per article by dr. (b)(6), "metallosis following silicone metacarpophalangeal joint arthroplasties with grommets: case report" there was a report of metallosis as a potential long term complication with the use of silicone arthroplasty. Hand (2012) 7:207-209 doi 10. 1007/s11552-012-9401-9. Orig. Surg - ten years earlier.
Patient Sequence No: 1, Text Type: D, B5
[11179203]
The 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
| Report Number | 1043534-2013-01534 |
| MDR Report Key | 3347468 |
| Report Source | 03 |
| Date Received | 2013-09-13 |
| Date of Report | 2013-09-12 |
| Date Mfgr Received | 2013-12-31 |
| Date Added to Maude | 2013-09-13 |
| 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 | 3 |
| 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 IMPLANT |
| Generic Name | SMALL JOINT COMPONENT, CODE:KYI |
| Product Code | KYI |
| Date Received | 2013-09-13 |
| 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 | 1. Required No Informationntervention | 2013-09-13 |