MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-11-04 for UNKNOWN_RECONSTRUCTIVE_PRODUCT UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[3780428]
It was reported that patient complained of pain and instability. Intraoperatively, the lateral femoral condyle on the femoral component was fractured.
Patient Sequence No: 1, Text Type: D, B5
[11217266]
Catalog number is unknown at this time. The device was reported as an unknown hinged howmedica femur. It was noted that the device is not available for evaluation due to hospital policy. Additional information has been requested and if received, will be provided in the supplemental report. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[18711217]
An event regarding the fracture of an unknown femoral component was reported. The event was not confirmed. A visual, dimensional, functional, or material analysis could not be performed as the devices were not returned for evaluation. Also no medical records were received for evaluation. A review of the device history records could not be performed as the product lot number was not provided. The investigation concluded that the exact cause of the event could not be determined because further information is needed. It also concluded that there is no indication the event is related to a manufacturing issue.
Patient Sequence No: 1, Text Type: N, H10
[18727743]
It was reported that patient complained of pain and instability. Intraoperatively, the lateral femoral condyle on the femoral component was fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2013-03548 |
| MDR Report Key | 3447913 |
| Report Source | 00,05 |
| Date Received | 2013-11-04 |
| Date of Report | 2013-10-09 |
| Date of Event | 2013-10-09 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2013-11-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. NIKU KASMAI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_RECONSTRUCTIVE_PRODUCT |
| Generic Name | IMPLANT |
| Product Code | HRZ |
| Date Received | 2013-11-04 |
| Catalog Number | UNK_REC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-04 |