MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-12-11 for UNKNOWN WRIST IMPLANT UNK WRIST manufactured by Depuy Orthopaedics Inc Us.
[185248651]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185248652]
The literature article entitled "wrist arthrodesis for failed total wrist arthroplasty? , written by brian d. Adams, md et al, published in the journal of hand surgery am, in 2016; was reviewed. This article reports on a study that evaluates the radiographic results of a surgical technique for conversion of a failed arthroplasty to an arthrodesis. The purpose of the study was to assess the radiographic outcome and complications in a series of failed twa? S converted to a complete wrist arthrodesis using a surgical technique consisting of a contoured cancellous femoral head structural allograft, a wrist arthrodesis plate, and optional supplementation with demineralized bone matrix and corticocancellous bone chips. Patients were treated with the biaxial prosthesis (two patients), depuy, and the other 16 patients were treated with non-depuy products. The biaxial prosthesis in both patients failed due to distal component loosening. Case 1 and case 13 were identified as having depuy products in the article. All patients claimed to have no pain, or mild pain at the final follow-up. No other complications were specified with the depuy joint reconstruction products within the article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-120021 |
| MDR Report Key | 9452429 |
| Report Source | LITERATURE |
| Date Received | 2019-12-11 |
| Date of Report | 2019-11-18 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2019-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| 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 | UNKNOWN WRIST IMPLANT |
| Generic Name | WRIST IMPLANT |
| Product Code | JWJ |
| Date Received | 2019-12-11 |
| Catalog Number | UNK WRIST |
| 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 US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-11 |