MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-06 for VANGUARD CRL MONO-LOCK TIBIAL BEARING 12X71 N/A 189262 manufactured by Biomet Orthopedics.
[19649932]
The user facility is outside of the united states. No medwatch report was received. 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: "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. "
Patient Sequence No: 1, Text Type: N, H10
[19658339]
It was reported that patient underwent total knee arthroplasty on (b)(6) 2010. Subsequently, a revision procedure was performed on (b)(6) 2012 due to instability associated with soft tissue laxity. The patella was resurfaced and the tibial bearing was removed and replaced with an anterior stabilized tibial bearing. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2012-00805 |
| MDR Report Key | 2599939 |
| Report Source | 01,07 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-05-08 |
| Date Mfgr Received | 2012-05-11 |
| Device Manufacturer Date | 2008-03-19 |
| 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 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 | VANGUARD CRL MONO-LOCK TIBIAL BEARING 12X71 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-06 |
| Model Number | N/A |
| Catalog Number | 189262 |
| Lot Number | 239790 |
| ID Number | N/A |
| Device Expiration Date | 2013-03-31 |
| 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 EAST BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-06 |