MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-06-16 for KRH FEMORAL COMPONENT 6475-3-932 manufactured by Stryker Orthopaedics-mahwah.
[14878565]
Revision of right krh femur. Metal condyle was broken
Patient Sequence No: 1, Text Type: D, B5
[15466894]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report. Not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002249697-2014-02320 |
| MDR Report Key | 3875354 |
| Report Source | 00,05 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-05-28 |
| Date of Event | 2014-05-28 |
| Date Mfgr Received | 2014-05-28 |
| Date Added to Maude | 2014-06-16 |
| 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 | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KRH FEMORAL COMPONENT |
| Generic Name | IMPLANT |
| Product Code | HSA |
| Date Received | 2014-06-16 |
| Catalog Number | 6475-3-932 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-06-16 |