MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-07-24 for NATURAL KNEE II NONPOROUS FEMORAL COMPONENT 630700031 manufactured by Zimmer, Inc..
[20103784]
It was reported that the patient received an implant on (b)(6) 2008 and underwent physical manipulation after experiencing pain and trouble walking, and less than 90 degrees rom.
Patient Sequence No: 1, Text Type: D, B5
[20177594]
Evaluation summary: the implanted components were confirmed as compatible. No devices or photos were received; therefore the condition of the components is unknown. Surgical notes were not provided. X-rays were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Rehabilitation protocol and adherence thereto is unknown. A definitive root cause cannot be determined with the information provided. However, the complaint may be revised upon return of x-rays and/or product or further information. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2013-01138 |
| MDR Report Key | 3249964 |
| Report Source | 04,07 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-06-24 |
| Date Mfgr Received | 2013-06-24 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2013-07-29 |
| 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 | NATURAL KNEE II NONPOROUS FEMORAL COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HSA |
| Date Received | 2013-07-24 |
| Catalog Number | 630700031 |
| Lot Number | 60819356 |
| Device Expiration Date | 2016-10-31 |
| 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 | 2013-07-24 |