MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-12-16 for UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTESION PI manufactured by Zimmer, Inc..
[1391691]
It is reported that the device was implanted in 2004 and that the patient was revised in 2005 due to a snapping-phenomenon, subluxation, dislocation and pain.
Patient Sequence No: 1, Text Type: D, B5
[8505611]
Evaluation summary: no product was returned for eval. Also, no x-rays were returned for review. Pt info such as height, weight, and pt activity is unk. Based on the available info, a definitive root cause cannot be ascertained at this time. No product was returned. Review of the device history records was also 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 | 1822565-2009-01202 |
| MDR Report Key | 1561185 |
| Report Source | 01,05,08 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-11-16 |
| Date of Event | 2005-02-10 |
| Date Mfgr Received | 2009-11-16 |
| Date Added to Maude | 2009-12-18 |
| 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 | BRIAN FIEDLER |
| 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 | UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTESION PI |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2009-12-16 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization; 2. Required No Informationntervention | 2009-12-16 |