MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-05 for VANGUARD PS POST N/A 32-483900 manufactured by Biomet Orthopedics.
[18348240]
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. Expiration date - unknown age of device - unknown device mfr. Date - unknown other - it is not known if the device was used appropriately, however, it was evaluated and found to be conforming and within specification. The mating component was also found to be conforming and met specification. This report filed june 5, 2009.
Patient Sequence No: 1, Text Type: N, H10
[18374996]
It was reported that patient underwent total knee arthroplasty utilizing a tibial bearing trial and ps post in 2009. The ps post released from trial during removal from the knee joint and fell into the incision without doctor or surgical team noticing. It was noticed on the post-op x-ray and the patient was taken back to the o. R. For removal of post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2009-00102 |
| MDR Report Key | 1398541 |
| Report Source | 07 |
| Date Received | 2009-06-05 |
| Date of Report | 2009-05-07 |
| Date of Event | 2009-04-10 |
| Report Date | 2009-05-07 |
| Date Reported to Mfgr | 2009-05-07 |
| Date Mfgr Received | 2009-05-07 |
| Date Added to Maude | 2009-06-05 |
| 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 | 3 |
| Event Location | 3 |
| 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, INSTRUMENT, ALIGNMENT |
| Product Code | IQO |
| Date Received | 2009-06-05 |
| Returned To Mfg | 2009-05-07 |
| Model Number | N/A |
| Catalog Number | 32-483900 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| 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 P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-06-05 |