MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-16 for FEMORAL HEAD 9026-029-00 manufactured by Zimmer Prosthetic Implant Division.
[17436708]
The patient presented to the orthopedic surgeon with cronic dislocation of his total hip. The intended procedure was to revise the acetabular liner with an elevated liner. During the revision surgery it was discovered that on the primary surgery a 32mm liner was used with a 28mm femoral head, this had been causing the chronic dislocation. The surgeon replaced the std. Liner with an elevated liner 32mm, and the femoral head with a 32mm femoral headdevice labeled for single use. Patient medical status prior to event: unknown. 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: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33458-1993-00006 |
| MDR Report Key | 6103 |
| Date Received | 1993-07-16 |
| Date of Report | 1993-06-15 |
| Date of Event | 1993-06-09 |
| Date Facility Aware | 1993-06-09 |
| Report Date | 1993-06-15 |
| Date Reported to FDA | 1993-06-15 |
| Date Reported to Mfgr | 1993-06-15 |
| Date Added to Maude | 1993-08-05 |
| 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 | FEMORAL HEAD |
| Generic Name | FEMORAL HEAD |
| Product Code | JDD |
| Date Received | 1993-07-16 |
| Catalog Number | 9026-029-00 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5795 |
| Manufacturer | ZIMMER PROSTHETIC IMPLANT DIVISION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-07-16 |