MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-03 for BIOMET ILOK PRI TIB TRAY 67MM N/A 141212 manufactured by Biomet Orthopedics.
[32661372]
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, number 15 states,? Interoperative or postoperative bone fracture and/or postoperative pain.?
Patient Sequence No: 1, Text Type: N, H10
[32661373]
It was reported that patient underwent total knee arthroplasty on (b)(6) 2012. Subsequently, patient was revised on (b)(6) 2015 due to a tibial bone fracture. During the procedure, the bearing and tibial tray were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[35232569]
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04880 |
| MDR Report Key | 5265371 |
| Date Received | 2015-12-03 |
| Date of Report | 2015-12-17 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2015-12-17 |
| Device Manufacturer Date | 2011-11-27 |
| Date Added to Maude | 2015-12-03 |
| 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 | 3 |
| Event Location | 3 |
| 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 ILOK PRI TIB TRAY 67MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2015-12-03 |
| Model Number | N/A |
| Catalog Number | 141212 |
| Lot Number | 621210 |
| ID Number | N/A |
| Device Expiration Date | 2011-09-30 |
| 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 | 2015-12-03 |