MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-09 for MILLER/GALANTE POROUS TOTAL KNEE SYSTEM FIBER METAL 8505-852-37 manufactured by Zimmer.
[4474]
On 11/17/87 this patient had a left knee arthroplasty. On 7/9/93 this patient had a revision of patellar component. There was cracking and fragmentation of the polyethylene component and the metal backing of the patella was also removedinvalid data - regarding single use labeling of device. 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. Invalid data - regarding whether event presents imminent hazard. 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: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6251 |
| MDR Report Key | 6251 |
| Date Received | 1993-08-09 |
| Date of Report | 1993-07-21 |
| Date of Event | 1993-07-09 |
| Date Facility Aware | 1993-07-09 |
| Report Date | 1993-07-21 |
| Date Reported to FDA | 1993-07-21 |
| Date Reported to Mfgr | 1993-07-21 |
| Date Added to Maude | 1993-08-20 |
| 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 |
| Brand Name | MILLER/GALANTE POROUS TOTAL KNEE SYSTEM FIBER METAL |
| Generic Name | PATELLAR DOME 37MM |
| Product Code | MBD |
| Date Received | 1993-08-09 |
| Catalog Number | 8505-852-37 |
| Lot Number | 51-49800 |
| ID Number | UHMWPE |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 5938 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-09 |