MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-06-06 for VANGUARD CR MONO-LOCK DCM TIBIAL BEARING 12X79MM N/A 189702 manufactured by Biomet Orthopedics.
[2786312]
It was reported patient underwent total knee arthroplasty on (b)(6) 2012, utilizing a poly bearing. During the procedure the surgeon noted a scratch and elected not to implant. Another poly bearing of the same size was used to finish the procedure with no delay or patient injury.
Patient Sequence No: 1, Text Type: D, B5
[9829753]
Although examination of returned device found product to be non-conforming, it is unknown as to when the reported condition occurred. Quality inspection criteria was found to contain adequate verification checks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00776 |
| MDR Report Key | 2600770 |
| Report Source | * |
| Date Received | 2012-06-06 |
| Date of Report | 2012-04-23 |
| Date of Event | 2012-04-17 |
| Date Mfgr Received | 2012-04-23 |
| Device Manufacturer Date | 2012-02-15 |
| Date Added to Maude | 2012-10-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST 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 | VANGUARD CR MONO-LOCK DCM TIBIAL BEARING 12X79MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | BSN |
| Date Received | 2012-06-06 |
| Returned To Mfg | 2012-04-25 |
| Model Number | N/A |
| Catalog Number | 189702 |
| Lot Number | 430480 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-06 |