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..
[137750565]
Literature citation: morgan et al. The long-term outcome of silastic implant arthroplasty of the first metatarsophalangeal joint: a retrospective analysis of one hundred and eight feet. International orthopaedics. 2012, 36:1865-1869. 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
[137750566]
Allegedly, in an article by morgan et al, titled "the long-term outcome of silastic implant arthroplasty of the first metatarsophalangeal joint: a retrospective analysis of one hundred and eight feet" the authors report implant removal from 3 feet.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1043534-2019-00024 |
MDR Report Key | 8388235 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
Date Received | 2019-03-04 |
Date of Report | 2019-02-03 |
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 |