MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-21 for SIGNATURE KNEE GUIDES 04-05 N/A 42-422461 manufactured by Biomet Orthopedics.
[2724677]
It was reported that patient underwent total knee arthroplasty utilizing signature knee guides on (b)(6), 2012. During the procedure, the surgeon noted external rotation when using the guides. Additionally, a drill pin fractured in the patient's femur and had to be removed. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
[9922111]
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 receiving certificate of conformance showed that lot released with no recorded anomaly or deviation. Device will be forwarded to supplier manufacturer for evaluation. Upon receipt of the evaluation, a follow up medwatch will be submitted to the fda. Evaluation of planning and procedures determined the performance specifications of the device were achieved. For the investigation, the device history record was examined. Based on this information, an inaccurate position for the femur bone according to the hip was found. This position influences the femur implant rotation and it is possible that the femoral rotation could have been inaccurate but not more than 2 degrees. The root cause could not be determined. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-00878).
Patient Sequence No: 1, Text Type: N, H10
[10085221]
This follow-up report is being sent to correct the initial medwatch, originally, it was stated that the device had been returned and was in the process of being evaluated, but the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00879 |
| MDR Report Key | 2623637 |
| Report Source | 01,07 |
| Date Received | 2012-06-21 |
| Date of Report | 2012-04-25 |
| Date of Event | 2012-04-25 |
| Date Mfgr Received | 2012-04-25 |
| Device Manufacturer Date | 2012-03-30 |
| Date Added to Maude | 2012-06-21 |
| 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 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST 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 | SIGNATURE KNEE GUIDES 04-05 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-21 |
| Returned To Mfg | 2012-05-17 |
| Model Number | N/A |
| Catalog Number | 42-422461 |
| Lot Number | 050491 |
| ID Number | N/A |
| Device Expiration Date | 2012-09-30 |
| 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 EAST BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-21 |