UNKNOWN GREEN 29.9 A-SYMETRIC PATELLA TRIAL
Received Nov 29, 2012 · Event occurred Nov 12, 2012
Report 2249697-2012-02491 · MDR key 2858548
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Device Slipped
- Device Contamination with Chemical or Other Material
Patient
67 YR
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON HAD A PT 1 YEAR OUT OF SURGERY FOR A RIGHT TOTAL KNEE, WHO PRESENTED WITH PAIN IN THEIR KNEE. SURGEON TOOK X-RAYS WHICH SHOWED A SHADOW AND THE SURGEON THOUGHT THE PATELLA MAY HAVE COME LOOSE. WHEN SURGEON OPERATED ON PT TO REVISE, SURGEON NOTICED THE GREEN PATELLA TRIAL FROM ORIGINAL SURGERY WAS LEFT IN THE PT AND THAT IS THE SHADOW THAT APPEARED ON THE X-RAY. ALL OF THE PT'S ORIGINAL IMPLANT PARTS WERE CHECKED AND ALL WERE IN EXCELLENT CONDITION AND LEFT IN PT. SURGEON REMOVED TRIAL THAT WAS LEFT IN THE PT AND UNDOUBTEDLY CAUSING THE PT PAIN ON (B)(6) 2012.
Additional Manufacturer Narrative
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other