MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-02-24 for BIOMET ILOK PRI TIB TRAY 71MM N/A 141213 manufactured by Biomet Orthopedics.
[38902314]
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 1 states, "material sensitivity reactions. " number 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity. " this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2016-00615 / 00617).
Patient Sequence No: 1, Text Type: N, H10
[38902315]
It was reported that patient underwent an initial knee arthroplasty in 2007 or 2008. Subsequently, the patient was revised on (b)(6) 2016 due to metallosis, subluxation, and poly wear. The femoral, poly bearing and tibial tray were removed.
Patient Sequence No: 1, Text Type: D, B5
[41993178]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Requested but not returned by hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-00615 |
| MDR Report Key | 5457269 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-24 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-01-29 |
| Date Mfgr Received | 2016-03-07 |
| Device Manufacturer Date | 2006-01-16 |
| Date Added to Maude | 2016-02-24 |
| 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 | 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 71MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2016-02-24 |
| Model Number | N/A |
| Catalog Number | 141213 |
| Lot Number | 766010 |
| ID Number | N/A |
| Device Expiration Date | 2016-01-31 |
| 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 | 2016-02-24 |