MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-06 for BIOMET INTERLOK 83MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR N/A 141236 manufactured by Biomet Orthopedics.
[2791319]
It was reported patient underwent total knee arthroplasty on (b)(6) 2011. Subsequently, patient was revised on (b)(6) 2011, due to pain from tibial tray loosening.
Patient Sequence No: 1, Text Type: D, B5
[9830111]
The user facility is outside of the united states. No medwatch report was received. 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 under possible adverse effects number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity. "
Patient Sequence No: 1, Text Type: N, H10
[16243754]
Surface roughness of the underside of the tibial tray did not meet required specifications. However, with the damage to the surface following the device being explanted, it cannot be determined if the device met specification at initial implantation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00787 |
| MDR Report Key | 2599929 |
| Report Source | 01,07 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-05-10 |
| Date Mfgr Received | 2012-05-10 |
| Device Manufacturer Date | 2010-10-06 |
| Date Added to Maude | 2012-06-06 |
| 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 |
| 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 | BIOMET INTERLOK 83MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-06 |
| Returned To Mfg | 2012-06-06 |
| Model Number | N/A |
| Catalog Number | 141236 |
| Lot Number | 619880 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-06 |