MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-29 for MAESTRO TOTAL WRIST TAPERED CARPAL HEAD 7MM X 15MM STANDARD N/A 180363 manufactured by Biomet Orthopedics.
[63607355]
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.
Patient Sequence No: 1, Text Type: N, H10
[63607356]
It was reported the patient underwent total wrist arthroplasty and is being considered for a revision procedure due to unknown reasons.
Patient Sequence No: 1, Text Type: D, B5
[66575645]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative infection and/or allergic reaction. " review of sterilization certification confirms device was sterilized in accordance with iso 11137-2. Device product code? Kwn. (b)(4). Concomitant products: maestro total wrist radial stem: catalog #:180182, lot #:003990. Maestro total wrist right distal radial body: catalog #:180151, lot #:490430. Maestro total wrist capitate stem for tapered plate: catalog #:180320, lot #:961000. Maestro total wrist tapered carpal plate: catalog #:180395, lot #:741150. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-05448 and 1825034-2017-00432).
Patient Sequence No: 1, Text Type: N, H10
[66575646]
It was reported the patient underwent revision total wrist arthroplasty 19 days post-implantation due to infection. The carpal head and two screws were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[75831719]
This follow-up report is being submitted to relay corrected information. Root cause remains undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-05448 |
| MDR Report Key | 6214297 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-29 |
| Date of Report | 2017-05-16 |
| Date of Event | 2016-11-21 |
| Date Mfgr Received | 2017-05-16 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2016-12-29 |
| 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 | MAESTRO TOTAL WRIST TAPERED CARPAL HEAD 7MM X 15MM STANDARD |
| Generic Name | PROSTHESIS, WRIST |
| Product Code | KWN |
| Date Received | 2016-12-29 |
| Model Number | N/A |
| Catalog Number | 180363 |
| Lot Number | 133000 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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. Other; 3. Required No Informationntervention | 2016-12-29 |