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 BIOMET TIBIAL LOCKING BAR N/A 141205 manufactured by Biomet Orthopedics.
[17970612]
It was reported that patient with a history of infection underwent knee revision on (b)(6) 2012. A subsequent revision procedure was performed on (b)(6) 2012 due to infection. The joint was washed out and the bearing was removed and washed then reimplanted. The locking bar was removed and replaced. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
[18176963]
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. Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2. There are warnings in the package insert that state that this type of event can occur: "early or late postoperative infection and allergic reaction. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-00803 / 00804).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00804 |
| MDR Report Key | 2599968 |
| Report Source | 01,07 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-05-06 |
| Date Mfgr Received | 2012-05-10 |
| Device Manufacturer Date | 2012-01-22 |
| 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 | 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 | BIOMET TIBIAL LOCKING BAR |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-06 |
| Model Number | N/A |
| Catalog Number | 141205 |
| Lot Number | 747020 |
| ID Number | N/A |
| Device Expiration Date | 2012-01-31 |
| 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 |