FDA Adverse Event
Injury
Summary report: N
21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL
MDR report key: 1620559
·
Received February 5, 2010
Report
- Report Number
- 9616680-2009-00666
- Event Type
- Injury
- Date Received
- February 5, 2010
- Date of Event
- March 12, 2007
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS
- Product Code
- LZO
- PMA / PMN Number
- K013106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENT 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 ARE 5 EVENTS ASSOCIATED WITH THIS EVENT TYPE (POTENTIAL MANUFACTURING ERROR AND PRODUCT CODE LZO).
Description of Event or Problem · 1
POST OPERATIVE ADVERSE RESULT. IT WAS REPORTED, "PROBLEM WITH PAIN AFTER HIP REVISION SURGERY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS | NA | 9798601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |