MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-23 for BIOMET OFFSET TIBIAL TRAY 83MM N/A 141486 manufactured by Biomet Orthopedics.
[5735782]
Patient underwent unicompartmental knee reconstruction of the left knee in 1982 due to a motorcycle accident that occurred in 1972. Patient was converted to a left total knee system on (b)(6) 1986 due to poly wear with lysis of the distal femur and proximal tibia and loosening. A left knee revision procedure was performed on (b)(6) 2005 due to instability. It is not known if biomet products were used in any of these procedures. A left knee revision procedure took place on (b)(6) 2009 due to aseptic loosening of the femoral and tibial components and a biomet total knee was implanted. Patient's left knee was revised again on (b)(6) 2011 due to femoral loosening. It was found that the patient also had metallosis. Another left knee revision procedure was performed on (b)(6) 2012 due to femoral subsidence. Patient underwent an irrigation and debridement on (b)(6) 2013 due to soft tissue mass with possible osteomyelitis of the tibia. No products were revised during the i&d procedure.
Patient Sequence No: 1, Text Type: D, B5
[13229272]
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: "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, excessive weight, and/or excessive unusual and/or awkward movement and/or activity. " this report is number 4 of 5 mdrs filed for the same patient (reference 1825034-2015-01252 & 01254 & 01255 & 01748 & 01749).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-01748 |
| MDR Report Key | 4724547 |
| Report Source | 05,07 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-03-31 |
| Date of Event | 2009-02-09 |
| Date Mfgr Received | 2015-03-31 |
| Device Manufacturer Date | 2002-02-10 |
| Date Added to Maude | 2015-04-23 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 OFFSET TIBIAL TRAY 83MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2015-04-23 |
| Model Number | N/A |
| Catalog Number | 141486 |
| Lot Number | 079740 |
| ID Number | N/A |
| Device Expiration Date | 2007-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-04-23 |