MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-04-26 for OXFORD UNI FEMORAL MD N/A 154601 manufactured by Biomet Uk, Ltd..
[2752869]
It was reported via clinical study that patient underwent partial knee arthroplasty on (b)(6) 2007. Subsequently, the patient was revised on (b)(6) 2011, due to pain. The tibial tray, tibial bearing, and femoral stem were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[9818413]
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, number twenty states, "persistent pain". This report is number 1 of 3 mdrs filed for the same event (reference 1825034-2012-00540 / 00542).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00540 |
| MDR Report Key | 2550872 |
| Report Source | 00 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-03-29 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2012-03-29 |
| Device Manufacturer Date | 2006-06-06 |
| Date Added to Maude | 2012-04-27 |
| 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 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXFORD UNI FEMORAL MD |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BTK |
| Date Received | 2012-04-26 |
| Model Number | N/A |
| Catalog Number | 154601 |
| Lot Number | 1186947 |
| ID Number | N/A |
| Device Expiration Date | 2016-05-31 |
| 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 ESTATES BRIDGEND, SOUTH WALES CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-26 |