MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-03-20 for STANDARD BUSHING, MRS 2442-0-305 manufactured by Howmedica Osteonics Corp..
[284238]
It was reported that the patient underwent revision surgery to replace a worn bushing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-2003-00031 |
| MDR Report Key | 449338 |
| Report Source | 07 |
| Date Received | 2003-03-20 |
| Date of Report | 2003-02-14 |
| Date of Event | 2003-01-27 |
| Date Mfgr Received | 2003-02-14 |
| Date Added to Maude | 2003-03-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 300 COMMERCE COURT |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD BUSHING, MRS |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2003-03-20 |
| Model Number | NA |
| Catalog Number | 2442-0-305 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 438322 |
| Manufacturer | HOWMEDICA OSTEONICS CORP. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 070702584 US |
| Baseline Brand Name | STANDARD BUSHING |
| Baseline Generic Name | ARTIFICIAL KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 2442-0-305 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K811630 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-03-20 |