FDA Adverse Event
Injury
Summary report: N
ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
MDR report key: 2963528
·
Received February 15, 2013
Report
- Report Number
- 0002249697-2013-00683
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 21, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THE EVENT AS NOT CONFIRMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL RECORDS WERE PROVIDED. REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CHR INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
PATIENT REQUIRED REVISION DUE TO SUBSIDING STEM.
Description of Event or Problem · 1
PATIENT REQUIRED REVISION DUE TO SUBSIDING STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68058 | ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | 37213606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |