MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-03-04 for SWANSON FINGER JOINT IMPLANT manufactured by Wright Medical Technology, Inc..
[1459875]
Per article "avanta versus swanson silicone implants in the mcp joint--a prospective, randomized comparison of 30 pts followed for 2 yrs", in the j hand surg br. 2005 feb;30(1):8-13. , moller k, sollerman c, geijer m, kopylov p, and tagil m. Report "fracture of the silicone spacer occurred with 8 swanson implants. "
Patient Sequence No: 1, Text Type: D, B5
[8440834]
Investigation is not complete. Event code is addressed in the package insert. Trends will be evaluated. This report will be updated when the investigation is complete. This literature source did not provide info on the implantation dates, nor dates of complications. This report will be updated when the investigation is complete. This event occurred in (b) (6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2010-00068 |
| MDR Report Key | 1623724 |
| Report Source | 01 |
| Date Received | 2010-03-04 |
| Date of Report | 2010-02-25 |
| Date Mfgr Received | 2010-02-25 |
| Date Added to Maude | 2010-03-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| 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 |
| Product Code | KWF |
| Date Received | 2010-03-04 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | ARLINGTON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-03-04 |