MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-04-30 for FINN SEGMENTAL FEMORAL 153804 manufactured by Biomet, Inc..
[246305]
Revision left total arthroplasty performed in 1999. Due to pain and instability, revision performed in 2002. Surgeon noted rotation of femoral component intraoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2002-00044 |
| MDR Report Key | 391035 |
| Report Source | 06 |
| Date Received | 2002-04-30 |
| Date of Report | 2002-04-29 |
| Date of Event | 2002-02-27 |
| Date Mfgr Received | 2002-03-29 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2002-05-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BETH ALBERT, AST |
| Manufacturer Street | PO BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINN SEGMENTAL FEMORAL |
| Generic Name | PROSTHESIS, KNEE, COMP |
| Product Code | KRQ |
| Date Received | 2002-04-30 |
| Model Number | NA |
| Catalog Number | 153804 |
| Lot Number | 026010 |
| ID Number | NA |
| Device Expiration Date | 2009-07-01 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 380081 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | FINN SEGMENTAL FEMORAL |
| Baseline Generic Name | PROSTHESIS, KNEE, COMP |
| Baseline Model No | NA |
| Baseline Catalog No | 153804 |
| Baseline ID | NA |
| Baseline Device Family | FINN SEGMENTAL FEMORAL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 120 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K974558 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2002-04-30 |