MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for BIOMET POR PRI TIB TRAY 67MM N/A 141262 manufactured by Biomet Orthopedics.
[38857217]
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. 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
[38857218]
It was reported a patient underwent a left total knee arthroplasty on an unknown date approximately 11 years ago. Subsequently, the patient was revised on (b)(6) 2016 due to laxity and osteolysis. During the revision procedure, the surgeon noted the bearing had worn through, causing the locking bar to fracture. A piece of the locking bar remains in the patient. The femoral component, bearing, and tibial component were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[45578924]
This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch. Date implanted - approximately 11 years ago. This report is number 1 of 2 mdr's filed for the same patient (reference 1825034-2016-00588 / 01650).
Patient Sequence No: 1, Text Type: N, H10
[45578925]
During a knee revision procedure approximately 11 post-implantation due to laxity and osteolysis, it was noted that the tibial bearing had worn through, causing the locking bar to fracture. A piece of the locking bar was retained by the patient.
Patient Sequence No: 1, Text Type: D, B5
[47905205]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Review of the device confirmed the reported condition. A conclusive root cause of the event could not be determined. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states,? Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.?
Patient Sequence No: 1, Text Type: N, H10
[47905206]
During a knee revision procedure occurring approximately 16 years post-implantation due to laxity and osteolysis, it was noted that the tibial bearing had worn through, causing the locking bar to fracture. A piece of the locking bar was retained by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-00588 |
| MDR Report Key | 5455474 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2000-02-17 |
| Date Added to Maude | 2016-02-23 |
| 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 POR PRI TIB TRAY 67MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2016-02-23 |
| Returned To Mfg | 2016-04-14 |
| Model Number | N/A |
| Catalog Number | 141262 |
| Lot Number | 955430 |
| ID Number | N/A |
| Device Expiration Date | 2005-02-28 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2016-02-23 |