FDA Adverse Event
Malfunction
Summary report: N
JAPANESE OMNIFIT EON CS 132 NKSIZE 9 STEM 40 MM 13
MDR report key: 1082454
·
Received July 22, 2008
Report
- Report Number
- 9616680-2008-00216
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- April 23, 2008
- Report Date
- April 23, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWY
- PMA / PMN Number
- K020989
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE SURGERY THE NURSE FOUND THE HOLE IN THE TYVEK SHEET WHEN SHE OPENED THE OUTER BOX OF THE STEM SIZE #9 (J6098-0940). THEN THE SURGEON USED SIZE #8 STEM (J6098-0835) INSTEAD OF #9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JAPANESE OMNIFIT EON CS 132 NKSIZE 9 STEM 40 MM 13 | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | 12201202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |