MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-05 for BIOMET 9.5 MM DISK DRILL TIP 423872 * manufactured by Biomet. Inc..
[20350092]
Pt underwent complex left total hip arthroplasty revision of femoral compnent and modular exchange of acetabular component polyethylene liner. Left hip joint total synovectomy for polythylene wear debris syndrome and exchange of acetabular component, modular locking mechanism. Moreland osteotomes and a ultradrive cement remover with a 9. 5 mm disc drill tip were used to remove cement. During this portion of the procedure the tip broke off its shaft in the femoral canal. An intraoperative x-ray showed that the tip had migrated down to the junction of the middle and distal third of the femur. An attempt to grasp it with a ronguer was unsuccessful and the tip was left in the intramedullary distal aspect of the femoral canal. Used in conjunction with ultradrive handpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041261 |
| MDR Report Key | 790825 |
| Date Received | 2006-12-05 |
| Date of Report | 2006-12-05 |
| Date of Event | 2006-11-22 |
| Date Added to Maude | 2006-12-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET 9.5 MM DISK DRILL TIP |
| Generic Name | * |
| Product Code | LZV |
| Date Received | 2006-12-05 |
| Model Number | 423872 |
| Catalog Number | * |
| Lot Number | 376980 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 778481 |
| Manufacturer | BIOMET. INC. |
| Manufacturer Address | PO 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 | 423872 |
| 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. Other | 2006-12-05 |