MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-02-27 for NEXGEN CR-FLEX FEMORAL COMPONENT 00595201702 manufactured by Zimmer, Inc..
[3172374]
It is reported that the patient was revised due to pain.
Patient Sequence No: 1, Text Type: D, B5
[10522863]
Evaluation summary: no devices, photos, patient factor information, surgical notes or x-rays were received. Pain can be influenced by many factors. These factors include, but are not limited to, patient weight, patient activity, bone quality, implant size, surgical technique, and rehabilitation program. A definitive root cause cannot be determined with the information provided. Evaluation: review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2013-00405 |
| MDR Report Key | 2984921 |
| Report Source | 04,07 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-01-28 |
| Date of Event | 2011-08-03 |
| Date Mfgr Received | 2013-01-28 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2013-03-04 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN CR-FLEX FEMORAL COMPONENT |
| Product Code | HSA |
| Date Received | 2013-02-27 |
| Catalog Number | 00595201702 |
| Lot Number | 60406949 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-27 |