MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-09 for VANGUARD PS TIBIAL TRIAL POST N/A 32-483900 manufactured by Biomet Orthopedics.
[1736438]
It was reported that patient underwent total knee arthroplasty on (b)(6) 2010. Subsequently, at one month post-operative radiographs, surgeon noted that the tibial trial post was implanted within the patient. Revision surgery was performed on (b)(6) 2010, to remove the trial post.
Patient Sequence No: 1, Text Type: D, B5
[1844619]
It was reported patient underwent total knee arthroplasty on (b)(6) 2010. Subsequently, at one month post-operative radiographs, surgeon noted that the tibial trial post was implanted within the patient. Revision surgery was performed on (b)(6) 2010, to remove the trial post.
Patient Sequence No: 1, Text Type: D, B5
[8857364]
The lot number information needed to review device history records was unavailable. This report submitted (b)(6) 2010.
Patient Sequence No: 1, Text Type: N, H10
[8961127]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00510 |
| MDR Report Key | 1894500 |
| Report Source | 07 |
| Date Received | 2010-11-09 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-10-09 |
| Date Facility Aware | 2010-11-04 |
| Date Mfgr Received | 2010-10-12 |
| Date Added to Maude | 2010-11-10 |
| 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 | 3 |
| Manufacturer Contact | MR. JEREMY SCHROEDER |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743713755 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANGUARD PS TIBIAL TRIAL POST |
| Generic Name | DEVICE, PROSTHESIS, ALIGNMENT |
| Product Code | IQO |
| Date Received | 2010-11-09 |
| Model Number | N/A |
| Catalog Number | 32-483900 |
| Lot Number | UNKNOWN |
| 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 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-11-09 |