FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P - JAPANESE TWIN PACK
MDR report key: 1193519
·
Received October 8, 2008
Report
- Report Number
- 9610726-2008-00075
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- August 27, 2008
- Report Date
- September 12, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- N17004
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT RECEIVED THE PRIMARY SURGERY USING HMRS AND SIMPLEX P CEMENT. WITHIN ONE DAY POST-OP, THE PT DID NOT RETURN TO CONSCIOUSNESS AND DIED. AN AUTOPSY ON THIS PT WAS PERFORMED AND FOUND THAT HE DIED IN PULMONARY EMBOLISM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P - JAPANESE TWIN PACK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |