FDA Adverse Event
Death
Summary report: N
ZIMMER
MDR report key: 184661
·
Received August 26, 1998
Report
- Report Number
- 1822565-1998-00102
- Event Type
- Death
- Date Received
- August 26, 1998
- Date of Event
- July 14, 1998
- Report Date
- July 31, 1998
- Manufacturer
- ZIMMER, INC.
- Product Code
- LOD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A FEMORAL HEAD REPLACEMENT SURGERY, BONE CEMENT WAS APPLIED. BEFORE SUTURING TISSUE AND AFTER POLYMERIZATION, PT'S PULSE AND BLOOD PRESSURE DROPPED SUDDENLY. PT WAS RECOVERED MOMENTARILY BY CARDIO PULMONARY RESUSCITATION BUT EVENTUALLY DIED OF CARDIOGENIC SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER Implant | LVC BONE CEMENT SGL 80/40/KIT | LOD | ZIMMER, INC. | NA | 53787800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Death |