MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-20 for NEUFLEX MCP IMPLANT SZ 40 123440000 manufactured by Depuy Orthopaedics, Inc. 1818910.
[95366950]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary ==> no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Review of inspection criteria finds the product and lot combination met specification. Review of the did not reveal any related deviations or anomalies. Device history lot ==> null. Device history lot ==> null. Device history review ==> null.
Patient Sequence No: 1, Text Type: N, H10
[95366951]
Medwatch report received stated that mcp implant placed 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 with deviation noted at rip joint. Patient seen with doctor, who reviewed treatment options including pip joint fusion vs working with hand ot to see how much mobility can recovered. Doctor warned that patient may develop increase 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 obtain 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 hinge. Doi: (b)(6) 2016; dor: (b)(6) 2017 affected side: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2017-52210 |
| MDR Report Key | 7133910 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-20 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2016-01-04 |
| Date Added to Maude | 2017-12-20 |
| 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. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUFLEX MCP IMPLANT SZ 40 |
| Generic Name | NEUFLEX IMPLANT : FINGER IMPLANT |
| Product Code | KYJ |
| Date Received | 2017-12-20 |
| Catalog Number | 123440000 |
| Lot Number | 723814 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-20 |