MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-01 for TAPERLOC COMPLETE RASP/PROVISIONAL 10MM X 140MM N/A 51-203100 manufactured by Biomet Orthopedics.
[19749506]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. The user facility was notified of the event on (b)(4), 2011. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. This report filed (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
[19844669]
It was reported that patient underwent a total hip arthroplasty utilizing an instrument (rasp) to prepare the femoral canal on (b)(6), 2011. During the procedure, the surgeon noted foreign black material on the rasp after it had been used. The patient was administered a longer course of antibiotics post surgery as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2011-00065 |
| MDR Report Key | 1976224 |
| Report Source | 07 |
| Date Received | 2011-02-01 |
| Date of Report | 2011-01-06 |
| Date of Event | 2011-01-04 |
| Date Facility Aware | 2011-02-01 |
| Date Mfgr Received | 2011-01-06 |
| Device Manufacturer Date | 2010-09-14 |
| Date Added to Maude | 2011-02-01 |
| 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. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743711132 |
| 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 | TAPERLOC COMPLETE RASP/PROVISIONAL 10MM X 140MM |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-02-01 |
| Model Number | N/A |
| Catalog Number | 51-203100 |
| Lot Number | 408860 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 3 MO |
| 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 | 2011-02-01 |