FDA Adverse Event
Injury
Summary report: N
OMNIFIT EON CS 127 NK SIZE 7 STEM 35 MM 12
MDR report key: 1221887
·
Received November 4, 2008
Report
- Report Number
- 2249697-2008-00340
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 8, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWY
- PMA / PMN Number
- K983226
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT REVISED FOR A LOOSE CEMENTED STEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT EON CS 127 NK SIZE 7 STEM 35 MM 12 | IMPLANT | KWY | STRYKER ORTHOPAEDICS MAHWAH | NA | 79041001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |