MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2017-03-01 for UNKNOWN MAESTRO WRIST RADIAL COMPONENT N/A manufactured by Biomet Orthopedics.
[68661268]
Current information is insufficient to permit conclusions as to the cause of the events. Event details and product identification were not provided for the patient mentioned in the journal article. (b)(4). Initial reporter - culp, randall w. ; bachoura, abdo; gelman, scott e. ; and jacoby, sidney m.
Patient Sequence No: 1, Text Type: N, H10
[68661269]
Information was received based on review of a journal article titled, " proximal row carpectomy combined with wrist hemiarthroplasty " which aimed to present early experience with proximal row carpectomy (prc) combined with distal radius hemiarthroplasty using the maestro wrist reconstructive system radial component, manufactured by legacy biomet from april 2009 to june 2010. A competitor product was used from september 2010 onwards. Seventeen patients were identified in the article that underwent proximal row carpectomy combined with distal radius hemiarthroplasty with a maestro radial component on an unknown date. Mean postoperative flexion, extension, and grip strength were all less than preoperative levels. It was reported that an (b)(6) female with a history of osteoarthritis underwent right wrist arthroplasty. Patient subsequently experienced ulnar tunnel syndrome and underwent ulnar nerve neurolysis and ulnar tunnel decompression. At the 24 month followup, patient reported pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-01262 |
| MDR Report Key | 6367743 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-03-01 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN MAESTRO WRIST RADIAL COMPONENT |
| Generic Name | PROSTHESIS, WRIST |
| Product Code | KWN |
| Date Received | 2017-03-01 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| 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 | 2017-03-01 |