MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-03-02 for MOST HINGE KIT 500000100 manufactured by Zimmer, Inc..
[1289031]
Upon separation of the distal femur, the surgeon noticed some black substance on the male & female taper. She also noted that the junction between the segment and the stem had no gap. Also, the junction between the condylar end & segment had no gap.
Patient Sequence No: 1, Text Type: D, B5
[8454820]
(b) (4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2010-00106 |
| MDR Report Key | 1622285 |
| Report Source | 05,08 |
| Date Received | 2010-03-02 |
| Date of Report | 2010-02-10 |
| Date of Event | 2010-01-26 |
| Date Mfgr Received | 2010-02-01 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2010-03-09 |
| 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 | MOST HINGE KIT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2010-03-02 |
| Returned To Mfg | 2010-02-16 |
| Model Number | NA |
| Catalog Number | 500000100 |
| Lot Number | 1371337 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-03-02 |