MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-20 for ZIMMER 9027-28 manufactured by Zimmer.
[4810]
While the surgeon was placing the hip through a range of motion, the 28mm provisional head popped off and subsequently could not be found. It migrated anteriorly to the acetabulum and was unretrievable by the surgeon. The surgeon stated that there was no injury to the patient. Invalid data - regarding single use labeling of device. 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. Invalid data - whether 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. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33153-1993-00006 |
| MDR Report Key | 6768 |
| Date Received | 1993-09-20 |
| Date of Report | 1993-08-03 |
| Date of Event | 1993-07-20 |
| Date Facility Aware | 1993-07-23 |
| Report Date | 1993-08-03 |
| Date Reported to FDA | 1993-08-03 |
| Date Reported to Mfgr | 1993-08-03 |
| Date Added to Maude | 1993-10-15 |
| 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 | ZIMMER |
| Generic Name | FEMORAL HEAD PROVISIONAL 28MM |
| Product Code | JDD |
| Date Received | 1993-09-20 |
| Model Number | 9027-28 |
| Catalog Number | 9027-28 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6451 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-09-20 |