MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-03-04 for SWANSON UNK manufactured by Wright Medical Technology, Inc..
[137784407]
Literature citation: taniguchi et al. Recurrence of deformity after silicone implant and resection arthroplasty of the metatarsophalangeal joint for rheumatoid arthritis: long-term results. Modern rheumatology. 27:2, 266-270. Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[137784408]
Allegedly, in an article by taniguchi et al, titled "recurrence of deformity after silicone implant and resection arthroplasty of the metatarsophalangeal joint for rheumatoid arthritis: long-term results" the authors describe the implant integrity at final follow-up as "deformation or suspected fragmentation" in 9 feet and "visible fracture of the stem or the hinge" in 2 feet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2019-00022 |
| MDR Report Key | 8388231 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-03-04 |
| Date of Report | 2019-02-03 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2019-02-03 |
| Date Added to Maude | 2019-03-04 |
| 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 | MR MATTHEW PARRISH |
| Manufacturer Street | 1023 CHERRY RD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON 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 |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2019-03-04 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-04 |