MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-11-21 for TITANIUM FEMORAL STEM UNK manufactured by Stryker Orthopaedics Mahwah.
[19899793]
"patient reported having "issues" with his hip, requiring multiple surgeries. He reported having his right hip replaced in 2000, followed by a revision in 2003. In 2003, he reported that it was a stryker implant (with a titanium femoral stem). He claims that he had to have the stryker stem revised in 2005 because the femoral piece fractured. Product identification and medicals are pending. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249697-2005-00131 |
| MDR Report Key | 648827 |
| Report Source | 07 |
| Date Received | 2005-11-21 |
| Date of Report | 2005-10-31 |
| Date of Event | 2005-01-05 |
| Date Mfgr Received | 2005-10-31 |
| Date Added to Maude | 2005-12-05 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 1201831500 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TITANIUM FEMORAL STEM |
| Generic Name | IMPLANT |
| Product Code | JDD |
| Date Received | 2005-11-21 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 638313 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | * MAHWAH NJ 07430 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-21 |