MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-22 for FEMORAL HEAD IMPLANT 9026-029 manufactured by Zimmer Product Service Distribution Center.
[7032]
On 1/11/94 a femoral head was implanted on a ceentralign stem. Everything appeareed to be alright.. On 2/24/94 the pt complained of paain, an x-ray was taken aand the femoral head showeeed to have come loose from the femoral stem. On 2/28/94 revision surgery was performed and the femoral head was removed from the pt, the morse taper on the stem was examineed by the surgeon and appeared to be alright. A new femoral head was placed on the stemmm and tightnesss was tested by the surgeon and was satisfactory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33458-1994-00002 |
| MDR Report Key | 14273 |
| Date Received | 1994-03-22 |
| Date of Report | 1994-03-22 |
| Date of Event | 1994-02-24 |
| Date Facility Aware | 1994-02-24 |
| Report Date | 1994-03-02 |
| Date Reported to FDA | 1994-03-02 |
| Date Reported to Mfgr | 1994-03-02 |
| Date Added to Maude | 1994-06-24 |
| 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 |
| 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 IMPLANT |
| Generic Name | FEMORAL HEAD |
| Product Code | JDD |
| Date Received | 1994-03-22 |
| Returned To Mfg | 1994-03-02 |
| Model Number | NA |
| Catalog Number | 9026-029 |
| Lot Number | 50020600 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 14269 |
| Manufacturer | ZIMMER PRODUCT SERVICE DISTRIBUTION CENTER |
| Manufacturer Address | 1777 W. CENTER STREET WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-22 |