FDA Adverse Event
Injury
Summary report: N
SIMPLEX BONE CEMENT
MDR report key: 1851055
·
Received September 29, 2010
Report
- Report Number
- 9610726-2010-00336
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- October 11, 2006
- Report Date
- September 9, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- NDN
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SIMPLEX BONE CEMENT NOT CURING APPROPRIATELY AND PATELLA HAD TO BE REMOVED AND RE-PREPARED, CEMENT HAD TO BE REMOVED AND RE-APPLIED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX BONE CEMENT | IMPLANT | NDN | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |