MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-24 for OXFORD UNICOMPARTMENTAL TIBIAL BEARING SM SZ3 N/A 154618 manufactured by Biomet Orthopedics.
[2638869]
It was reported that patient underwent partial knee arthroplasty (b)(6) 2005. Subsequently, a revision procedure was performed (b)(6) 2012 due to wear and fracture. The bearing was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[9888993]
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. " malalignment or soft tissue imbalance can place inordinate forces on the components which may cause excessive wear to the patellar or tibial bearing articulating surfaces. "
Patient Sequence No: 1, Text Type: N, H10
[10689093]
The report for this event was duplicated. The event was also reported under manufacturer report number 3002806535-2013-00015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00676 |
| MDR Report Key | 2587582 |
| Report Source | 07 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-04-26 |
| Date of Event | 2012-04-30 |
| Date Mfgr Received | 2012-04-26 |
| Device Manufacturer Date | 2004-08-07 |
| Date Added to Maude | 2012-05-24 |
| 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 | OXFORD UNICOMPARTMENTAL TIBIAL BEARING SM SZ3 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BTK |
| Date Received | 2012-05-24 |
| Model Number | N/A |
| Catalog Number | 154618 |
| Lot Number | 813925 |
| ID Number | N/A |
| Device Expiration Date | 2004-08-07 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-05-24 |