MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-13 for SWANSON UNK manufactured by Wright Medical Technology, Inc..
[130212889]
Literature citation: goldfarb et al. Metacarpophalangeal joint arthroplasty in rheumatoid arthritis. The journal of bone and joint surgery. 2003; 85-a : page(s) 1869-1878. 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
[130212890]
Allegedly, in an article by goldfarb et al. Titled "metacarpophalangeal joint arthroplasty in rheumatoid arthritis" it was reported that an investigation was performed to evaluate long term outcomes of patients. Thirty-seven hands were treated with a total of 148 swanson implants: eighty-four hp swanson implants were used (prior to 1986), and sixty-four hp-100 swanson implants were implanted. Of the 148 swanson implants, ninety-nine (67%) were broken, twenty-five (17%) were severely deformed, and twenty-four (16%) were intact. Forty-nine (58%) of the eighty-four hp swanson silicone implants (used prior to 1986) were fractured at an average of seventeen years after the surgery, and fifty (78%) of the sixty-four hp-100 swanson implants were fractured at an average of 12. 7 years. The patients were satisfied or very satisfied with the function of 38% (twenty) of the fifty-two hands, and they reported no pain in 27% (fourteen) of the fifty-two hands. There was pain, ranging from occasional to constant, in the other thirty-eight hands. The ability to perform activities of daily living, work capacity, satisfaction with the cosmetic appearance, and overall satisfaction varied considerably among the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00192 |
| MDR Report Key | 8160239 |
| Report Source | LITERATURE |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-16 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2018-12-13 |
| 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, FINGER, POLYMER |
| Product Code | KWF |
| Date Received | 2018-12-13 |
| 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 | 2018-12-13 |