MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for NEUFLEX 1234-40-000 123440000 manufactured by Depuy Orthopaedics, Inc..
[92216069]
Patient Sequence No: 1, Text Type: N, H10
[92216070]
Mcp implant placed during right index mp silastic arthroplasty. Patient experienced symptom relief a couple of months after. Later in the year, xrays reviewed - arthroplasty well incorporated. Significant arthritis w/ deviation noted at pip joint. Patient seen with doctor, who reviewed treatment options including pip joint fusion vs working with hand ot to see how much mobility can be recovered. Doctor warned that patient may develop increased pain at her pip joint while working on rom but patient is interested in proceeding. Plan for return to clinic in 2 months. Patient returned with increased pain and swelling. Fluoroscopic imaging obtained today shows the implant appears well seated in the proximal phalanx and metacarpal with no evidence of osteolysis. However it looks as though the implant may be broken at the hinge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7036849 |
| MDR Report Key | 7036849 |
| Date Received | 2017-11-16 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-08-04 |
| Report Date | 2017-11-08 |
| Date Reported to FDA | 2017-11-08 |
| Date Reported to Mfgr | 2017-11-08 |
| Date Added to Maude | 2017-11-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUFLEX |
| Generic Name | PROSTHESIS, FINGER, CONSTRAINED, POLYMER |
| Product Code | KYJ |
| Date Received | 2017-11-16 |
| Model Number | 1234-40-000 |
| Catalog Number | 123440000 |
| Lot Number | 723814 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-16 |