MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-06 for UNKNOWN ASCENT FEMORAL COMPONENT N/A ASCENT FEMORAL COMPONENT- UNK manufactured by Biomet Orthopedics.
[18804447]
Current information is insufficient to permit a conclusion as to the cause of the event. The product and lot identification necessary to review manufacturing history was not provided.
Patient Sequence No: 1, Text Type: N, H10
[19107271]
It was reported that patient underwent a patient-matched knee arthroplasty procedure on unknown date. Subsequently, a mid-shaft fracture of the femoral stem occurred. It is unknown whether a revision procedure has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2012-00799 |
| MDR Report Key | 2600610 |
| Report Source | 07 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-11 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-06-06 |
| 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 | UNKNOWN ASCENT FEMORAL COMPONENT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-06 |
| Model Number | N/A |
| Catalog Number | ASCENT FEMORAL COMPONENT- UNK |
| Lot Number | UNK |
| 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 | 2012-06-06 |