MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-03-28 for OXFORD ANATOMIC BEARING RT MD SIZE 5 N/A 159577 manufactured by Biomet U.k. Ltd..
[2577766]
It was reported that patient underwent partial knee arthroplasty on (b)(6) 2009. Subsequently, the patient began to experience pain after suffering a fall and a revision procedure was performed on (b)(6) 2012. All components were removed and replaced with a competitor's total knee system. The surgeon noted wear on the bearing that was revised.
Patient Sequence No: 1, Text Type: D, B5
[9720924]
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. There are warnings in the package insert that state that this type of event can occur: "excessive activity, trauma and weight gain may contribute to premature failure of the implant by loosening, fracture, and/or wear. " evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. The user facility was notified of the event. Should the user facility submit a medwatch report or provide additional information, biomet will forward a supplemental report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[9961303]
Evaluation of the returned component found evidence of parallel wear scratches on the underside that run in the anterior-posterior direction. A couple of deeper gouges are also visible, likely due to explantation. The bearing surface shows wear scratches that are straight on the posterior half, but have a distinctive curvature as the scratch reaches the anterior half. The medial posterior corner also displays a large degree of material deformation and a dull surface finish distinctive from the shiny appearance of the rest of the part. The likely cause of failure was the presence of osteophytes on the medial posterior end of the femur that extended beyond the femoral component of the oxford knee. Although the presence of osteophytes would explain all the features seen on the part, their presence cannot be verified objectively.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00349 |
| MDR Report Key | 2508163 |
| Report Source | 07 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-01 |
| Date of Event | 2012-02-29 |
| Date Mfgr Received | 2012-03-01 |
| Device Manufacturer Date | 2008-02-05 |
| Date Added to Maude | 2012-03-29 |
| 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 | 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 ANATOMIC BEARING RT MD SIZE 5 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BTK |
| Date Received | 2012-03-28 |
| Returned To Mfg | 2012-03-15 |
| Model Number | N/A |
| Catalog Number | 159577 |
| Lot Number | 1459845 |
| ID Number | N/A |
| Device Expiration Date | 2013-01-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET U.K. LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATE BRIDGEND CF313XA US CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-03-28 |