MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for HARRIS/GALANTE BONE SCREW 6624-65-15,20,25,30,35 manufactured by Zimmer.
[848]
68 year old male 3+ years post left toatal hip replacement with displacement. Readmitted for excision of extensive histiofibrocytic reaction with cypt formation extraction of broken screws & metal shell and inner polyethylene high density liner, replacement of acetabulum & the morse taper headdevice 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination, other. Results of evaluation: component failure, none or unknown, none or unknown. Conclusion: device failure related to patient condition. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 864 |
| MDR Report Key | 864 |
| Date Received | 1992-07-01 |
| Date of Report | 1992-06-23 |
| Date of Event | 1992-05-27 |
| Date Facility Aware | 1992-05-27 |
| Report Date | 1992-06-23 |
| Date Reported to FDA | 1992-06-23 |
| Date Reported to Mfgr | 1992-05-27 |
| Date Added to Maude | 1992-07-10 |
| 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 | HARRIS/GALANTE BONE SCREW |
| Product Code | HWD |
| Date Received | 1992-07-01 |
| Model Number | 6624-65-15,20,25,30,35 |
| Lot Number | 66632700,67525300,66116000,ETC |
| Device Availability | Y |
| Device Age | 01-OCT-89 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 823 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-01 |