MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for SWANSON FINGER JOINT IMPLANT WITH GROMMETS G470-0004 manufactured by Wright Medical Technology, Inc..
[38990407]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. No information provided (malfunction).
Patient Sequence No: 1, Text Type: N, H10
[38990408]
It was reported via medwatch # (b)(4), that the "product malfunctioned. Pre-op diagnosis-rheumatoid arthritis hand procedure: right re-do metacarpophalangeal joints (mcpj), silastic metacarpophalangeal joint arthroplasty (smpa) digits 2-5. Post-op diagnosis was the same. " no further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2016-00015 |
| MDR Report Key | 5439060 |
| Date Received | 2016-02-16 |
| Date of Event | 2015-01-19 |
| Date Facility Aware | 2016-02-09 |
| Date Added to Maude | 2016-02-16 |
| 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 Street | 1023 CHERRY ROAD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 901290-566 |
| 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 | 0 |
| Brand Name | SWANSON FINGER JOINT IMPLANT WITH GROMMETS |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | KWF |
| Date Received | 2016-02-16 |
| Catalog Number | G470-0004 |
| Lot Number | 047431996 |
| 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 | 2016-02-16 |