MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-06-01 for VANGUARD CR TIBIAL BEARING 12X71/75 N/A 183422 manufactured by Biomet Orthopedics.
[2641027]
Information received from an independent laboratory indicates that a patient underwent knee arthroplasty on (b)(6) 2005. It was further reported that the tibial bearing was revised approximately four years later due to loosening and malposition. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
[9891171]
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: "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. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. " information received from the independent laboratory was very limited in nature. Follow up attempts to obtain more detailed information have been unsuccessful to date. In the event that additional details pertaining to event information are received, a follow up medwatch will be submitted to the fda. The following sections could not be completed with the limited information available: the date of the revision procedure is unknown, but was reported to have taken place approximately four years after initial implantation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00750 |
| MDR Report Key | 2596140 |
| Report Source | 00 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-05-03 |
| Date Mfgr Received | 2012-05-03 |
| Device Manufacturer Date | 2005-09-04 |
| Date Added to Maude | 2012-06-01 |
| 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 CR TIBIAL BEARING 12X71/75 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-01 |
| Model Number | N/A |
| Catalog Number | 183422 |
| Lot Number | 819630 |
| ID Number | N/A |
| Device Expiration Date | 2010-08-30 |
| 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 EAST BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-01 |