MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1991-12-31 for SURGICAL SIMPLEX P manufactured by Howmedica.
[46]
During repair fractured hip, patient became hypotensive at time of application of bone cement, methyl methacrylate. Post -operative head cat scan revealed large infarct cerebellum. Patient expired the following day. Know adverse reaction of methyl methacrylate include: cerebrovascular accident, myocardial infarction, cardiac arrest, sudden deathdevice 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 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: invalid data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 132 |
| MDR Report Key | 132 |
| Date Received | 1991-12-31 |
| Date of Report | 1991-12-19 |
| Date of Event | 1991-12-13 |
| Date Facility Aware | 1991-12-13 |
| Report Date | 1991-12-19 |
| Date Reported to FDA | 1991-12-19 |
| Date Reported to Mfgr | 1991-12-19 |
| Date Added to Maude | 1992-03-30 |
| 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 | SURGICAL SIMPLEX P |
| Generic Name | METHYL METHACRYLATE |
| Product Code | JXH |
| Date Received | 1991-12-31 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 130 |
| Manufacturer | HOWMEDICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1991-12-31 |