MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-05-15 for UNKNOWN NEXGEN KNEE COMPONENT manufactured by Zimmer, Inc..
[19732727]
It is reported that the patient received a right knee implant in 2010 and was revised due to an unknown reason. It is also reported that the patient's leg was later amputated.
Patient Sequence No: 1, Text Type: D, B5
[19833861]
Information was received from a consumer who is not required to complete form 3500a. Evaluation summary: neither surgical notes nor x-rays were provided; therefore, fit and orientation could not be evaluated. Patient factors that may effect the performance of the components such as bone quality, activity level or type of activity (low impact vs. High impact) are unknown. A definitive root cause cannot be determined with the information provided. Evaluation codes: review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable. 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 available information, 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 | 1822565-2013-00802 |
| MDR Report Key | 3129548 |
| Report Source | 04,07 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-04-19 |
| Date Mfgr Received | 2013-04-19 |
| Date Added to Maude | 2013-05-28 |
| 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 | UNKNOWN NEXGEN KNEE COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HSA |
| Date Received | 2013-05-15 |
| 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 | 2013-05-15 |