FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3022556
·
Received March 27, 2013
Report
- Report Number
- 0002249697-2013-01074
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 1, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE II STEM SIZE 5. IT WAS NOTED THAT THE DEVICE AND MEDICAL RECORDS WOULD NOT BE PROVIDED DUE TO THE HOSPITAL'S POLICY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STEM SUBSIDENCE AND WAS REVISED IN ONE STAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125827 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| O| R |