MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-13 for CT SIGNATURE KNEE GUIDES 03-05 N/A 42-422456 manufactured by Biomet Orthopedics.
[10036092]
Supplier has completed a review of the image quality, segmentation, planning, and guide design for this case. Following the investigation, no root cause could be identified.
Patient Sequence No: 1, Text Type: N, H10
[19334627]
The user facility is outside of the united states. No medwatch report was received. Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation.
Patient Sequence No: 1, Text Type: N, H10
[19362341]
It was reported that patient underwent signature knee arthroplasty on (b)(6), 2012. After drilling the distal femoral pins, it was noted that the pin holes were incorrectly rotated. The procedure was completed, but only after a delay of more than half an hour had occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2012-00850 |
| MDR Report Key | 2614415 |
| Report Source | 01,07 |
| Date Received | 2012-06-13 |
| Date of Report | 2012-05-21 |
| Date of Event | 2012-05-08 |
| Date Mfgr Received | 2012-05-21 |
| Device Manufacturer Date | 2012-04-08 |
| Date Added to Maude | 2012-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| 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 | CT SIGNATURE KNEE GUIDES 03-05 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-13 |
| Model Number | N/A |
| Catalog Number | 42-422456 |
| Lot Number | 050996 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-06-13 |