FDA Adverse Event Injury Summary report: N

SMITH AND NEPHEW JOURNEY KNEE REPLACEMENT

MDR report key: 2071860 · Received April 22, 2011

Report

Report Number
MW5020391
Event Type
Injury
Date Received
April 22, 2011
Date of Event
December 20, 2010
Report Date
April 22, 2011
Manufacturer
SMITH AND NEPHEW
Product Code
JWH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(6) 2007, A SMITH AND NEPHEW "JOURNEY" KNEE REPLACEMENT WAS PERFORMED. (B)(6) 2010, THE KNEE IMPLANT "DISLOCATED" WHILE I WAS SITTING AT MY DESK AT WORK. I CALLED MY DR, WAS ASKED TO COME IN AND DID SO AND WAS ADMITTED TO THE HOSP FOR A "REVISION" SURGERY WHICH WAS PERFORMED ON (B)(6). THEY WERE UNABLE TO MANUALLY MANIPULATE THE KNEE BACK INTO PLACE, OPEN THE KNEE AND INSERTED A LARGER POST. (B)(6) 2011, I EXHIBITED SOME SYMPTOMS OF A STROKE WHILE AT WORK. CALLED 911 AND WAS TAKEN TO THE HOSP AND TEST RESULTS CONFIRM I HAD A WHAT APPEARED TO BE 2 TIA'S OR STROKE. (B)(6) 2011, WHILE SITTING AT HOME AND ADJUSTING MY SEATING POSITION THE KNEE DISLOCATED FOR THE 2ND TIME. CALLED 911 AND WAS TAKEN TO THE HOSP AND SEEN BY THE ATTENDING ORTHOPEDIC SURGEON ON CALL. SHE ATTEMPTED TO CONTACT MY PHYSICIAN TO VERIFY THAT IN (B)(6) THERE WAS AN ANGIOGRAM OF THE POSSIBLY COMPROMISED ARTERY AND TO ADVISE HIM OF MY CURRENT CONDITION. I WAS SEDATED AND THE ATTENDING ORTHOPEDIC SURGEON, HER ASSISTANT AND MY PHYSICIAN MANUALLY MANIPULATED THE KNEE BACK INTO PLACE. I WAS RELEASED AND TOLD TO SCHEDULE A PRESURGERY CONSULTATION WITH MY DR. THE KNEE HAD FAILED TWICE AND PLANS WERE TO REMOVE IT AND IMPLANT ANOTHER KNEE. (B)(6) 2011 UPON MEETING MY DR IN HIS OFFICE, I WAS TOLD THAT WHEN HE CALLED THE MFR'S REP TO TELL HIM OF THE 2ND EVENT, TO HIS SURPRISE THE MFR'S REP TOLD HIM THERE HAD BEEN REPORTS OF THIS PROBLEM, AND THAT THERE WAS A CUSTOM IMPLANT TO CORRECT THE PROBLEM. SURGERY IS SCHEDULED FOR (B)(6) 2011 IF A CUSTOM PART TO "FIT ME" IS AVAILABLE, IF NOT THEY WILL HAVE TO CUSTOM MAKE ONE AND SURGERY WOULD BE THE FOLLOWING WEDNESDAY. PHYSICAL THERAPY AFTER THE 1ST REVISION TO THE KNEE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SMITH AND NEPHEW JOURNEY KNEE REPLACEMENT JOURNEY KNEE JWH SMITH AND NEPHEW

Patients

Seq Age Sex Outcome Treatment
1 55 YR Hospitalization| O