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..
[137750954]
Literature citation: kanzaki et al. Flexible hinge silicone implant with or without titanium grommets for arthroplasty of the first metatarsophalangeal joint. Journal of orthopaedic surgery. 2014; 22(1): 42-45. 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
[137750958]
Allegedly, in an article by kanzaki et al, titled "flexible hinge silicone implant with or without titanium grommets for arthroplasty of the first metatarsophalangeal joint" the authors report "slight deformation or fracture of the stem or the hinge" in 25 joints and "complete deformation of the implant" in 4 joints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2019-00023 |
| MDR Report Key | 8388233 |
| 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 |