MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-11-19 for TIB BEARING COMP ROT/HIN KNEE 6475-3-933 manufactured by Stryker Orthopaedics Limerick.
[16300115]
It was reported that the device fractured. Patient was revised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610726-2004-00054 |
| MDR Report Key | 555854 |
| Report Source | 07 |
| Date Received | 2004-11-19 |
| Date of Report | 2004-10-29 |
| Date of Event | 2004-10-04 |
| Date Mfgr Received | 2004-10-29 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2004-11-23 |
| 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 | RITA INTORRELLA |
| Manufacturer Street | 325 CORPRATE DR |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIB BEARING COMP ROT/HIN KNEE |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2004-11-19 |
| Model Number | NA |
| Catalog Number | 6475-3-933 |
| Lot Number | KXUN |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 545502 |
| Manufacturer | STRYKER ORTHOPAEDICS LIMERICK |
| Manufacturer Address | * LIMERICK EI |
| Baseline Brand Name | TIB/BEARING COMP ROT/HIN KNEE |
| Baseline Generic Name | ARTIFICAL KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6475-3-933 |
| Baseline ID | NA |
| Baseline Device Family | TIBIAL BEARING |
| Baseline Shelf Life Contained | Y |
| 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 | 2004-11-19 |