MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-18 for BIOMET ILOK PRI TIB TRAY 71MM N/A 141213 manufactured by Biomet Orthopedics.
[31535998]
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 2 states,? Early or late postoperative infection and allergic reaction.? This report is based on allegations set forth in plaintiff? S complaint and the allegations contained therein are unverified. This report is number 1 of 4 mdrs filed for the same event (reference 1825034-2015-04718 / 04719 / 04720 / 04721).
Patient Sequence No: 1, Text Type: N, H10
[31535999]
Legal counsel for patient reported that patient underwent total right knee arthroplasty on (b)(6), 2013. Subsequently, patient's legal counsel further reports patient allegations of possible nickel allergy. There has been no reported revision procedure. This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
Patient Sequence No: 1, Text Type: D, B5
[40538447]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. (b)(4). 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 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and excessive activity. " number 6 states, "inadequate range of motion due to improper selection or positioning of components. " number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain. " this report is based on allegations set forth in plaintiff? S complaint and the allegations contained therein are unverified. This report is number 2 of 4 mdrs filed for the same event (reference 1825034-2015-04718 / 04719 / 04720 / 04721). Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[40538448]
Legal counsel for patient reported that patient underwent total right knee arthroplasty on (b)(6) 2013. Subsequently, patient's legal counsel further reports patient allegations of possible nickel allergy. There has been no reported revision procedure. This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified. Additional information received from patient's legal counsel noted a revision procedure was performed on (b)(6) 2014 due to patient allegations of loosening of the femoral component with varus collapse, nickel, aluminum and iron allergy, metal debris, bone erosion with inflammatory synovitis, pain, swelling, effusion, difficulty ambulating and crepitus.
Patient Sequence No: 1, Text Type: D, B5
[44176062]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44176063]
Legal counsel for patient reported that patient underwent total right knee arthroplasty on (b)(6) 2013. Subsequently, patient's legal counsel further reports patient allegations of possible nickel allergy. Additional information received from patient's legal counsel noted a revision procedure was performed on (b)(6) 2014 due to patient allegations of loosening of the femoral component with varus collapse, nickel, aluminum and iron allergy, metal debris, bone erosion with inflammatory synovitis, pain, swelling, effusion, difficulty ambulating and crepitus. This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified. Additional information received in operative notes reported that patient underwent a revision procedure on (b)(6) 2014 due to aseptic loosening of the femoral component with nickel allergy. During the procedure, metal debris, the removal of inflammatory synovial tissue, loosening of the femoral component with varus collapse and femoral condylar bone erosion were noted. The femoral components, tibial components and tibial bearing were removed and replaced with competitor product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-04718 |
| MDR Report Key | 5233748 |
| Report Source | OTHER |
| Date Received | 2015-11-18 |
| Date of Report | 2016-03-31 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2016-03-31 |
| Device Manufacturer Date | 2012-06-07 |
| Date Added to Maude | 2015-11-18 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 2015-11-18 |
| Model Number | N/A |
| Catalog Number | 141213 |
| Lot Number | 180980 |
| 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. Other | 2015-11-18 |