FDA Adverse Event
Death
Summary report: N
SIMPLEX P - US TOBRA FD 10-PK
MDR report key: 1730089
·
Received May 5, 2010
Report
- Report Number
- 9610726-2010-00139
- Event Type
- Death
- Date Received
- May 5, 2010
- Date of Event
- November 16, 2009
- Report Date
- April 14, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K014199
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. NO FURTHER INFO IS AVAILABLE AT THIS TIME, ALTHOUGH IT HAS BEEN REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PT SUFFERED A CARDIAC ARREST AFTER THE INJECTION OF THE BONE CEMENT, DURING PLACEMENT OF HER PROSTHESIS RIGHT TOTAL HIP REPLACEMENT REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P - US TOBRA FD 10-PK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MIQ053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |