FDA Adverse Event
Malfunction
Summary report: N
25MM MOD REV HIP BDY/BLT + 10MM/COMPONENT LEVEL 9006
MDR report key: 2472105
·
Received February 24, 2012
Report
- Report Number
- 9616680-2012-00123
- Event Type
- Malfunction
- Date Received
- February 24, 2012
- Date of Event
- July 22, 2011
- Report Date
- July 22, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K013106
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "RESTORATION MODULAR CONE/CONICAL BEING USED TO REPLACE A WRIGHT MEDICAL MODULAR STEM (NECK FRACTURE). BOLT FRACTURED DURING FINAL TORQUING. SURGEON DECIDED TO LEAVE IMPLANT IN PLACE. BOLT (+10) LOT CODE: CAXJC02."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 25MM MOD REV HIP BDY/BLT + 10MM/COMPONENT LEVEL 9006 | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 29525801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |