MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for BIOMET ILOK PRI TIB TRAY 75MM N/A 141214 manufactured by Biomet Orthopedics.
[32747917]
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. (b)(4). Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred. Should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.
Patient Sequence No: 1, Text Type: N, H10
[32747918]
It was reported patient underwent initial left knee arthoplasty on an unknown date. Subsequently, patient was revised on (b)(6) 2015 due to metallosis.
Patient Sequence No: 1, Text Type: D, B5
[35054031]
This follow-up report is being filed to relay corrected information and 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. 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 11 states, "wear and/or deformation of articulating surfaces. " this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-04893-1 / 2016-00003 / 2016-00004).
Patient Sequence No: 1, Text Type: N, H10
[35054032]
It was reported patient underwent initial left knee arthoplasty on (b)(6) 2013. Subsequently, patient was revised on (b)(6), 2015 due to metallosis. Additional information received reported that during the revision procedure on (b)(6), 2015, all components were removed and replaced with competitor product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-04893 |
| MDR Report Key | 5268665 |
| Date Received | 2015-12-04 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2015-12-15 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2015-12-04 |
| 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 75MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2015-12-04 |
| Model Number | N/A |
| Catalog Number | 141214 |
| Lot Number | 056750 |
| ID Number | N/A |
| 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 | 2015-12-04 |