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.
[170307082]
(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
[170307083]
The literature article entitled "total wrist replacement: a retrospective comparative study? Written by william cooney, md, et al; published in the journal of wrist surgery vol. 1 no. 2 in 2012; was reviewed. The purpose of the study is to report the institution? S experience with resectional arthroplasty versus resurfacing arthroplasty. The patients in the study were identified through the institutions total joint registry? S database. Between 1994 and 2006, 39 patients with 47 total wrist replacements were identified. One was excluded leaving 46 implants in 39 patients. Surgeries were performed by five different surgeons. There were three different implants used; the biaxial wrist replacement (depuy), and two other non-depuy implants. There were eight failures with the biaxial wrist prosthesis. One loose biaxial was successfully salvaged with a non-depuy total wrist replacement. Two biaxial arthroplasties with instability were salvaged by revision of the distal component. Five of the seven biaxial wrists with distal loosening ultimately required wrist fusion. Pain was improved in all patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-119823 |
| MDR Report Key | 9452407 |
| Report Source | LITERATURE |
| Date Received | 2019-12-11 |
| Date of Report | 2019-11-18 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2020-01-08 |
| 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 |