MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for PCA MODULAR TOTAL KNEE 6628-1-202/6628-1-313 manufactured by Howmedica.
[16147791]
Patient confused after surgery and was found sitting on edge of bed with legs between bedrails. Posey restraint strap broken. Patient refused to position self back on bed and two staff members were unable to lift patient to bed or chair and prevent patient from flexing knee and dislocating prosthesis. Returned to surgery 3/27/92 for replacement with modular total knee constraint tibial insert. Discharged to nursing home on 4/1/92device 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: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3308 |
| MDR Report Key | 3308 |
| Date Received | 1992-07-10 |
| Date of Report | 1992-04-14 |
| Date of Event | 1992-03-27 |
| Date Facility Aware | 1992-04-10 |
| Report Date | 1992-04-14 |
| Date Reported to Mfgr | 1992-04-14 |
| Date Added to Maude | 1993-04-15 |
| 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 | PCA MODULAR TOTAL KNEE |
| Product Code | KRN |
| Date Received | 1992-07-10 |
| Catalog Number | 6628-1-202/6628-1-313 |
| ID Number | 6628-1-950/66-2-100 |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Device Age | 01-MAR-92 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3088 |
| Manufacturer | HOWMEDICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-10 |