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 VANGUARD DCM CR TIBIAL BEARING 14MM X 71/75MM N/A 183444 manufactured by Biomet Orthopedics.
[2668085]
It was reported that patient underwent total knee arthroplasty on (b)(6) 2012. Subsequently, patient was revised on (b)(6) 2012, due to infection. The bearing was removed and replaced with another vanguard bearing.
Patient Sequence No: 1, Text Type: D, B5
[9927128]
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. 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 allergic reaction. " review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00843 |
| MDR Report Key | 2614414 |
| Report Source | 01,07 |
| Date Received | 2012-06-13 |
| Date of Report | 2012-05-21 |
| Date of Event | 2012-05-15 |
| Date Mfgr Received | 2012-05-21 |
| Device Manufacturer Date | 2009-11-30 |
| 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 | VANGUARD DCM CR TIBIAL BEARING 14MM X 71/75MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-13 |
| Model Number | N/A |
| Catalog Number | 183444 |
| Lot Number | 737220 |
| ID Number | N/A |
| Device Expiration Date | 2014-11-30 |
| 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 | 2012-06-13 |