MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-08-04 for NEUFLEX MCP IMPLANT SZ 40 123440000 manufactured by Depuy Orthopaedics, Inc.1818910.
[81812459]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[81812460]
Der states that patient is very active in horseback riding, cleaning stalls, etc. Surgeon felt patient had disrupted her collateral ligaments and took in for repair. Surgeon found disrupted collaterals but also 3 of 4 mcp nuflex implants (index, middle, ring) had broken at the post. Two of these (index/middle) had been implanted on (b)(6) 2013. The ring surgeon had revised and implanted new on (b)(6) 2016. Surgeon. Believed implant failure due to implant postponing exasperated by collateral ligament failure.
Patient Sequence No: 1, Text Type: D, B5
[83752990]
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. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s). Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2017-22264 |
| MDR Report Key | 6766969 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-08-04 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-07-07 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-08-04 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| 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 | FINGER IMPLANT |
| Product Code | KYJ |
| Date Received | 2017-08-04 |
| Catalog Number | 123440000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC.1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-04 |