FDA Adverse Event Injury Summary report: N

STRYKER

MDR report key: 2994294 · Received February 27, 2013

Report

Report Number
MW5029243
Event Type
Injury
Date Received
February 27, 2013
Date of Event
October 10, 2007
Report Date
February 27, 2013
Manufacturer
STRYKER
Product Code
JDI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THE EVENT: (B)(6) 2007 RIGHT TOTAL HIP REPLACEMENT UTILIZING STRYKER ACCOLADE SYSTEM WITH A 5.5 PRESS-FIT FEUMR WITH A +0 NECK AND 36MM COBALT CHROMIUM HEAD AND A 58MM PRESS-FIT HA-COATED ACETABULUM WITH A 10-DEGREE POSTERIOR LIP LINER INSERT. THE PROBLEM: ABOUT (B)(6) 2009, I CONTACTED THE ORTHOPEDIC SURGEON, (B)(6), REGARDING TRANSPLANTED AREA PAIN. HE DENIED THAT THE STRYKER HIP HE IMPLANTED WAS THE CAUSE OF MY PAIN BECAUSE IT HAD NOT BEEN RECALLED. ON (B)(6) 2009, ORTHOPEDIC SURGEON, (B)(6), ORDERED A BONE SCAN "PAIN RELATIVE TO THE RIGHT HIP". NOTHING SHOWED RELATIVE TO FAILURE OF THE HIP TRANSPLANT. ON OR ABOUT (B)(6) 2012 MY PRIMARY PHYSICIAN WHO IS ALSO MY CARDIOLOGIST, DR (B)(6), SPOKE WITH DR (B)(6), ABOUT MY PAINFUL HIP... AS I SAT THERE. AGAIN, DR (B)(6) DENIED ANY PROBLEMS WITH THE STRYKER HE PUT IN ME. I REQUESTED A SPECIFIC BLOOD TEST FOR COBALT AND CHROME AND DR (B)(6) ORDERED MY BLOOD DRAWN FOR THE PURPOSE OF FINDING OR NOT FINDING COBALT OR CHROME IN MY BODY. (B)(6) OF FDA EXPLAINS THAT INCOMPATIBILITY TWIXT THIS FORM AND MY IMAX COMPUTER HAS CAUSED PROBLEMS COMPLETING THIS FORM SUCH AS: MY DATE OF DEATH, CHECKING BOXES NOT RELATED TO MY SITUATION AT ALL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
84459 STRYKER ACCOLADE JDI STRYKER
84460 5.5 PRESS-FIT FEMUR FEMUR SYSTEM JDI STRYKER
84461 +D NECK NECK JDI STRYKER
84462 36MM COBALT CHROMIUM HEAD HEAD JDI STRYKER
84463 58MM PRESS FIT HA-COATED ACETABULUM JDI STRYKER
84464 10-DEGREE POSTERIOR LIP LINER INSERT LIP LINER INSERT JDI STRYKER

Patients

Seq Age Sex Outcome Treatment
1 74 YR