FDA Adverse Event
Death
Summary report: N
ACCOLADE (127 DEG) SIZE 2.5
MDR report key: 2885406
·
Received December 18, 2012
Report
- Report Number
- 9616680-2012-01435
- Event Type
- Death
- Date Received
- December 18, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE BHA SURGERY WHEN THE SURGEON WAS RASPING WITH FINAL BROACH, THE PT'S BLOOD PRESSURE START TO DROP GRADUALLY. THE PT'S CONDITION WAS NOT SO GOOD PRIOR TO THIS SURGERY. THEREFORE, DURING THE SURGERY, THE ANESTHESIST WAS SAYING THAT THE HIP SURGEON SHOULD FINISH THIS BHA AS SOON AS POSSIBLE. THE PT SUFFERED CARDIOPULMONARY ARREST AFTER ALL COMPONENTS WAS IMPLANTED IN THE OPERATING ROOM. DURING THE SUTURATION, THE PT ALTERNATED BETWEEN A RESUSCITATION AND A CARDIOPULMONARY. AS A RESULT, THE PT DIED AN HR AFTER THE BHA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE (127 DEG) SIZE 2.5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 40975404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |