MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-14 for VANGUARD PS TIBIAL BEARING 10X71/75MM N/A 183640 manufactured by Biomet Orthopedics.
[2765101]
It was reported patient underwent total knee arthroplasty (b)(6) 2009. A subsequent revision was performed (b)(6) 2012 due to pain, tibial lucency and metallosis. The femoral and bearing were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[9920197]
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. Listed under possible adverse effects: "material sensitivity reactions. " and "interoperative or postoperative bone fracture and/or postoperative pain. " evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. The tibial tray was also removed and reported to biomet spain (reference 9610576-2012-00009) this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-00836 / 00837).
Patient Sequence No: 1, Text Type: N, H10
[10018567]
Review of the explanted tibial bearing found examples of scratching and indentations consistent with third body wear debris. There is wear and surface damage on the anterior face of the tibial post consistent with damage caused by the femoral component during hyper-flexion. Root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00837 |
| MDR Report Key | 2616562 |
| Report Source | 07 |
| Date Received | 2012-06-14 |
| Date of Report | 2012-05-18 |
| Date of Event | 2012-04-22 |
| Date Mfgr Received | 2012-05-18 |
| Device Manufacturer Date | 2008-07-21 |
| Date Added to Maude | 2012-06-14 |
| 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 | 5742676639 |
| 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 PS TIBIAL BEARING 10X71/75MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-14 |
| Returned To Mfg | 2012-05-31 |
| Model Number | N/A |
| Catalog Number | 183640 |
| Lot Number | 509590 |
| ID Number | N/A |
| Device Expiration Date | 2013-07-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-06-14 |