MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-16 for ZIMMER TOTAL HIP FEM.HEAD-9026-33/ ACETABULAR UNK manufactured by Zimmer Inc..
[18144352]
Pt had a left total hip arthroplasty (harris-galante porous coated) on 6/3/88. Pt presented to the physician with progressive pain and increasing difficulty on ambulation left hip. Pt also has decreased range of motion left hip. On 10/13/98 pt underwent a revision of left total hip-acetabular component. At the time of surgery it was noted that the femoral component was well fixed as was the acetabular hgp acetabular porous component. The significant pathology was marked erosive changes and subluxation of the polyethylene liner. In summary, the appropriate polyethylene liner was changed with excellent fixation to the underlying acetabular shell. The 32mm head was converted to a 28mm head with respect to the femoral component which was well fixed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 197023 |
| MDR Report Key | 197023 |
| Date Received | 1998-10-16 |
| Date of Report | 1998-10-16 |
| Date of Event | 1998-10-13 |
| Date Facility Aware | 1998-10-13 |
| Report Date | 1998-10-16 |
| Date Reported to Mfgr | 1998-10-16 |
| Date Added to Maude | 1998-11-17 |
| 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 | 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 TOTAL HIP |
| Generic Name | HIP COMPONENTS/FEM.HEAD/STEM/ACETABULAR |
| Product Code | HND |
| Date Received | 1998-10-16 |
| Model Number | FEM.HEAD-9026-33/ ACETABULAR |
| Catalog Number | UNK |
| Lot Number | F.HEAD-61764700 F.STEM-5753890 |
| ID Number | ACETABULAR-60512700 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 10 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 191424 |
| Manufacturer | ZIMMER INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1998-10-16 |