FDA Adverse Event
Injury
Summary report: N
MOD CON DIST STEM 17 X 155 MM
MDR report key: 2132594
·
Received June 10, 2011
Report
- Report Number
- 9616680-2011-00380
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- October 20, 2010
- Report Date
- May 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K013106
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CLINIC CHART DATE (B)(6), 2010 INDICATES PATIENT HAD POSSIBLE DISLOCATION IN (B)(6) 2010 WHEN SHE WENT TO EMERGENCY ROOM ON ADVICE OF HER SURGEON."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOD CON DIST STEM 17 X 155 MM | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | CAXE623A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |