MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03 report with the FDA on 2012-06-13 for UNKNOWN OXFORD PHASE 3 IMPLANTS N/A manufactured by Biomet U.k. Ltd..
[2668604]
A journal article reported clinical outcomes for a study involving 216 patients who underwent 244 (28 bilaterals) unicompartmental knee arthroplasties for medial compartment osteoarthritis. Patients were followed a median of 4. 2 years (range 1 to 10. 4 years). Subsequently, there were 9 patients that underwent a revision procedure at a mean of 33 months after primary surgery.
Patient Sequence No: 1, Text Type: D, B5
[9879308]
The user facility is outside of the united states. No medwatch report was received. The information being reported was found in the journal article titled "oxford phase 3 unicompartmental knee arthroplasty: medium-term results of a minimally invasive surgical procedure". Knee surgery, sports traumatology, arthroscopy - volume 19, (b)(6), 2011 current information is insufficient to permit conclusions as to the cause of the events. Event details and product identification were not provided for the revision mentioned in the journal article. The following sections could not be completed with the limited information provided. Date of event - unknown. Expiration date - unknown. Date implanted - unknown. - date explanted - unknown. Initial reporter - the article was written by lukas a. Lisowski , michel p. J. Van den bekerom, peter pilot, c. Niek van dijk and andrzej e. Lisowski. - manufacture date - unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00830 |
| MDR Report Key | 2614431 |
| Report Source | 01,02,03 |
| Date Received | 2012-06-13 |
| Date of Report | 2012-05-16 |
| Date Mfgr Received | 2012-05-16 |
| Date Added to Maude | 2012-06-13 |
| 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 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 | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN OXFORD PHASE 3 IMPLANTS |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BTK |
| Date Received | 2012-06-13 |
| Model Number | N/A |
| Catalog Number | UNKNOWN OXFORD PHASE 3 |
| Lot Number | UNKNOWN |
| 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 U.K. 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 | 2012-06-13 |