MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-06 for OXFORD UNI TIBIA TRAY SZ C LM N/A 154722 manufactured by Biomet Uk Ltd..
[18803928]
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 it states "effusion" as an adverse event. This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2012-00411 / 00413).
Patient Sequence No: 1, Text Type: N, H10
[18979389]
Patient reported to have undergone partial knee arthroplasty on (b)(6), 2009 and that her knee recently buckled as she was stepping out of her car. Patient further reported that the knee swelled immediately and that her surgeon drained fluid/blood from her knee. An mri could not be performed due to the amount of swelling; however, an mri is planned. To date, there has been no report of a revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2012-00412 |
| MDR Report Key | 2521100 |
| Report Source | 04 |
| Date Received | 2012-04-06 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-03-02 |
| Date Mfgr Received | 2012-03-07 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2012-04-06 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | OXFORD UNI TIBIA TRAY SZ C LM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BTK |
| Date Received | 2012-04-06 |
| Model Number | N/A |
| Catalog Number | 154722 |
| Lot Number | 565103 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATE BRIDGEND, SOUTH WALES CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-06 |