FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 5062481
·
Received September 8, 2015
Report
- Report Number
- 0002249697-2015-02933
- Event Type
- Injury
- Date Received
- September 8, 2015
- Date of Event
- August 11, 2015
- Report Date
- August 11, 2015
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN BIPOLAR OMINFIT HFX. IT WAS NOTED THAT NO ADDITIONAL INFORMATION OR MEDICAL RECORDS WILL BE PROVIDED DUE TO HOSPITAL POLICY.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON REVISED A LEFT BIPOLAR STEM DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594170 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Hospitalization| R |