MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-07-07 for VANGUARD PS POST N/A 32-483900 manufactured by Biomet Orthopedics.
[16720764]
It was reported that patient underwent left knee arthroplasty in 2009. Subsequently, patient was seen for a routine post-operative visit where radiographs were taken. The radiographs indicated the presence of a metallic object in the patient's left knee. A revision was performed two months later, to remove the object which was confirmed to have been the posterior stabilizing post that came off of the trial bearing during the initial procedure.
Patient Sequence No: 1, Text Type: D, B5
[16907389]
Current information is insufficient to permit a conclusion as to the cause of the event. The lot number information needed to review device history records was unavailable. User facility report states that device is available for evaluation. User facility was contacted in an effort to obtain the device, however, it was relayed that the device was available for on-site evaluation only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2009-00130 |
| MDR Report Key | 1409724 |
| Report Source | 00 |
| Date Received | 2009-07-07 |
| Date of Report | 2009-06-08 |
| Date of Event | 2009-03-10 |
| Date Mfgr Received | 2009-06-08 |
| Date Added to Maude | 2009-07-07 |
| 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 | MRS. MIRANDA PARCELS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| 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 POST |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2009-07-07 |
| Model Number | N/A |
| Catalog Number | 32-483900 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-07-07 |