MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-26 for SWANSON FINGER JOINT UNK manufactured by Wright Medical Technology, Inc..
[131469432]
Literature citation: honkanen et al. Bioreconstructive poly-l/d-lactide implant compared with swanson prosthesis in metacarpophalangeal joint arthroplasty in rheumatoid patients: a randomized clinical trial. J hand surg eur. 2010; 0: 1-8. 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
[131469433]
Allegedly, in a 2010 literature article, honkanen, et al. Titled, biore constructive poly-l/d-lactide implant compared with swanson prosthesis in metacarpophalangeal joint arthroplasty in rheumatoid patients: a randomized clinical trial the authors mention 12 incidences of swanson finger implant breakage in situ and two cases of phalangeal cortex perforation from the implant. One in the index finger and one in the middle finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00201 |
| MDR Report Key | 8197949 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-12-26 |
| 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 | 2018-12-26 |
| 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 | 2018-12-26 |