MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2008-10-08 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT 00588001501 manufactured by Zimmer, Inc..
[946367]
It is reported that the patient started experiencing skin slough 15 days post-op. Ultimately, device was removed and spacer instead. Device was implanted in 2007 and revised the following year.
Patient Sequence No: 1, Text Type: D, B5
[8196672]
Other devices used: catalog #00598801015, nexgen complete knee solution stem extension straight, lot # unknown; catalog # 00588000400, nexgen complete knee solution rotating hinge knee tibial component, lot # unknown; catalog #00588005012, nexgen complete knee solution rotating hinge knee articular surface with hinge post extension, lot # unknown catalog #00588005012, nexgen complete knee solution all poly patella, lot # unknown was manufactured at zimmer. Manufacturing in another country. Evaluation summary: the product was not returned, nor were the x-rays available for review. The lot numbers are unknown. The cause of the skin slough and ultimate removal of the device can not be determined due to insufficient information. Evaluation: no product was returned. Review of the device history records was also not possible as the product and/or lot numbers required or 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 considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00689 |
| MDR Report Key | 1194444 |
| Report Source | 02,05,07 |
| Date Received | 2008-10-08 |
| Date of Report | 2008-09-08 |
| Date of Event | 2007-12-18 |
| Date Facility Aware | 2008-09-08 |
| Report Date | 2008-09-08 |
| Date Mfgr Received | 2008-09-08 |
| Date Added to Maude | 2008-10-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANN RECKTENWALL / KEVIN ESCAP |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2008-10-08 |
| Model Number | NA |
| Catalog Number | 00588001501 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1.5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1237897 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-10-08 |