MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-12-27 for UNKNOWN MAESTRO WRIST NI manufactured by Biomet Orthopedics.
[63312780]
Michael p. Gasper- "complications following partial and total wrist arthroplasty" 1-11. The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Initial reporter - jesse lou, patrick m. Kane, sidney m. Jacoby, a. Lee osterman, and randall w. Culp.
Patient Sequence No: 1, Text Type: N, H10
[63312781]
It was reported in a journal article that two patients initially underwent distal radius hemiarthroplasty. Both patients indicated infection (superficial) post-operatively. There has been no further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-05289 |
| MDR Report Key | 6204735 |
| Report Source | LITERATURE |
| Date Received | 2016-12-27 |
| Date of Report | 2016-12-27 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-12-27 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN MAESTRO WRIST |
| Generic Name | PROSTHESIS, WRIST |
| Product Code | KYI |
| Date Received | 2016-12-27 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-12-27 |