MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-06-22 for BIOMET OFFSET TIBIAL TRAY 71MM N/A 141483 manufactured by Biomet Orthopedics.
[19991480]
It was reported that patient underwent a left total knee arthroplasty on an unknown date. Subsequently, a revision procedure has been indicated due to an unknown reason; however, no revision procedure has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[20190701]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[26911987]
This follow up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Current information is insufficient to permit a conclusion as to the cause of the event. A review of device history records show the 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 warnings it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. " under warnings, number 6 states, "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. Revision surgery may be required to prevent component failure. "
Patient Sequence No: 1, Text Type: N, H10
[26911988]
It was reported that patient underwent a left total knee arthroplasty on (b)(6) 2015. Subsequently, a revision procedure was performed on (b)(6) 2015 due to malpositioning of the tibial tray. During the procedure, the tibial tray was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-02680 |
| MDR Report Key | 4859944 |
| Report Source | 01,07 |
| Date Received | 2015-06-22 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-07-14 |
| Device Manufacturer Date | 2014-03-30 |
| Date Added to Maude | 2015-06-22 |
| 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 71MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2015-06-22 |
| Model Number | N/A |
| Catalog Number | 141483 |
| Lot Number | 373480 |
| ID Number | N/A |
| Device Expiration Date | 2019-03-30 |
| 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 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-06-22 |