MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-27 for SWANSON FINGER JOINT UNK manufactured by Wright Medical Technology, Inc..
[131496375]
Literature citation: naghshineh et al. Proximal interphalangeal joint silicone arthroplasty for osteoarthritis: midterm outcomes. Hand. 2018; volume 0: 1-5. 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
[131496376]
Allegedly, in a 2018 literature article, by naghshineh et al. Titled proximal interphalangeal joint silicone arthroplasty for osteoarthritis: midterm outcomes, the authors describe a 20% revision rate for swanson finger joint arthroplasty of the pip joint. Additionally, the authors present significant rates of complications (37%), implant breakage (12%), instability (12%), chronic pain (9%), and stiffness (5%).
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1043534-2018-00204 |
MDR Report Key | 8199299 |
Report Source | LITERATURE |
Date Received | 2018-12-27 |
Date of Report | 2018-12-04 |
Date Mfgr Received | 2018-12-04 |
Date Added to Maude | 2018-12-27 |
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 FINGER JOINT |
Generic Name | PROSTHESIS, FINGER, POLYMER |
Product Code | KWF |
Date Received | 2018-12-27 |
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 | 2018-12-27 |