MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-02 for 32MM MG I POROUS PATELLA N/A 8505-852-32 manufactured by Zimmer, Inc..
[19958558]
The porous coating on the patella seperated from the metal. Patella and articulating surfacedevice labeled for single use. Patient medical status prior to event: satisfactory condition. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32549-1992-00004 |
| MDR Report Key | 1375 |
| Date Received | 1992-09-02 |
| Date of Report | 1992-08-25 |
| Date of Event | 1992-08-19 |
| Report Date | 1992-08-25 |
| Date Reported to FDA | 1992-08-25 |
| Date Reported to Mfgr | 1992-08-25 |
| Date Added to Maude | 1992-09-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 32MM MG I POROUS PATELLA |
| Generic Name | PATELLA BUTTON |
| Product Code | JOF |
| Date Received | 1992-09-02 |
| Model Number | N/A |
| Catalog Number | 8505-852-32 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1318 |
| Manufacturer | ZIMMER, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-09-02 |