FDA Adverse Event
Malfunction
Summary report: N
SHOULDER - HUMERAL FRACTURE 8MM LONG STEM
MDR report key: 1632721
·
Received March 5, 2010
Report
- Report Number
- 2249697-2009-00984
- Event Type
- Malfunction
- Date Received
- March 5, 2010
- Date of Event
- February 10, 2008
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- HSD
- PMA / PMN Number
- K062113
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (POTENTIAL MANUFACTURING ERROR) AND PRODUCT CODE HSD.
Description of Event or Problem · 1
POTENTIAL MANUFACTURING ERROR. IT WAS REPORTED THAT, "OPENED IMPLANT AND DISCOVERED NO HA COATING ON THE PROXIMAL PART OF THE STEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHOULDER - HUMERAL FRACTURE 8MM LONG STEM | IMPLANT | HSD | STRYKER ORTHOPAEDICS | NA | T2L70263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |