FDA Adverse Event
Injury
Summary report: N
ACCOLADE (127 DEG)
MDR report key: 1160474
·
Received September 12, 2008
Report
- Report Number
- 9616680-2008-00276
- Event Type
- Injury
- Date Received
- September 12, 2008
- Date of Event
- July 24, 2008
- Report Date
- August 18, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
REVISION OF STEM WAS REPORTED. REP PRESENTED AT ORIGINAL PROCEDURE BUT NOT AT REVISION AS A DEPUY PRODUCT WAS USED TO REPLACE. NOTHING SPECIFIC NOTED AT PRIMARY PROCEDURE. WHEN ASKED TO LOOK AT X-RAYS BY SURGEON AT ABOUT ONE YEAR POST OP, STEM IN VARUS WITH 3 POINT CONTACT AND LOOKED TO BE UNDERSIZED, ACCESS DIFFICULTY AT PRIMARY. STEM LOOSE AND CAME OUT EASILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE (127 DEG) | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 16845401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |