MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-05-20 for ULTRA-DRIVE DISK DRILL 423871 manufactured by Arthrotek/biomet.
[364951]
During revision total hip arthroplasty performed in 2004, it was reported that tool fractured during use of ultra drive cement removal system. Surgery was extended to remove disk drill tip from distal portion of the femur. Furthermore, during reattachment of the trochanter, it was reported that trochanter bolt fractured. No further details have been provided to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2004-00051 |
| MDR Report Key | 526187 |
| Report Source | 01,07 |
| Date Received | 2004-05-20 |
| Date of Report | 2004-05-14 |
| Date of Event | 2004-05-13 |
| Date Mfgr Received | 2004-05-14 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2004-05-25 |
| 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 | 0 |
| Manufacturer Contact | BETH ALBERT, ASSISTANCE |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | ARTHROTEK / BIOMET |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE DISK DRILL |
| Generic Name | CEMENT REMOVAL SYSTEM |
| Product Code | LZV |
| Date Received | 2004-05-20 |
| Model Number | NA |
| Catalog Number | 423871 |
| Lot Number | 732290 |
| ID Number | NA |
| Device Expiration Date | 2014-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 515341 |
| Manufacturer | ARTHROTEK/BIOMET |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | ULTRA-DRIVE DISK DRILL |
| Baseline Generic Name | CEMENT REMOVAL SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 423871 |
| Baseline ID | NA |
| Baseline Device Family | ULTRA-DRIVE DISK DRILL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900003 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-05-20 |