MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-25 for 5780 manufactured by Zimmer.
[781]
Revision total knee replacement done on a 70 year old female 7/24/92. The original prosthesis had been implanted on 7/14/86. Questionable possible titanium metallosisdevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1167 |
| MDR Report Key | 1167 |
| Date Received | 1992-08-25 |
| Date of Report | 1992-07-30 |
| Date of Event | 1992-07-24 |
| Date Facility Aware | 1992-07-24 |
| Report Date | 1992-07-30 |
| Date Reported to FDA | 1992-07-30 |
| Date Reported to Mfgr | 1992-07-24 |
| Date Added to Maude | 1992-09-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TOTAL KNEE PROSTHESIS |
| Product Code | KRN |
| Date Received | 1992-08-25 |
| Model Number | 5780 |
| Lot Number | 58213300,567370,572644, ETC. |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1115 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-08-25 |