FDA Adverse Event Malfunction Summary report: N

R3

MDR report key: 3207034 · Received June 27, 2013

Report

Report Number
3207034
Event Type
Malfunction
Date Received
June 27, 2013
Date of Event
June 10, 2013
Report Date
June 27, 2013
Manufacturer
SMITH & NEPHEW ORTHOPAEDICS, LTD.
Product Code
KWZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THIS PATIENT HAD AN MRI WHICH SHOWED METALLOSIS, AND ASPIRATION HAS BEEN NEGATIVE FOR INFECTION, PER THE MD NOTE. LAB FINDINGS: COBALT, S 204 H NG/ML 0.0-0.9;CHROMIUM, S 147.1 H NG/ML <0.3. FINDINGS FROM THE OPERATIVE REPORT: "INTRAOPERATIVELY DARK BROWN COFFEE-COLORED FLUID STAIN CAPSULAR TISSUE, MILD OSTEOLYSIS OF THE UPPER ASPECTS OF THE STEM ONLY FOR APPROXIMATELY 5-8 MM, BUT THE STEM WAS FIRMLY SEATED. THE CUP WAS FIRMLY SEATED WITH ONLY 1 TO 2 MM OSTEOLYSIS IN THE ZONES OF 9 TO 3 O'CLOCK. THERE WAS NO MARKINGS OF THE HEAD. THERE WAS NO MARKINGS OF THE CUP. THERE WAS METALLOSIS DEBRIS IN THE POSTERIOR ASPECTS OF THE HEAD AND ALSO AT THE TRUNNION INTERFACE. THE TRUNNION WAS INTACT ON THE STEM."..."THE UPPER ASPECTS OF THE STEM HAD NEAR OR MAYBE 5 TO 8 MM OSTEOLYSIS BUT RADIOGRAPHICALLY, THE STEM WAS SOLID AS WELL AS EQUAL CLINICALLY. A FULL SYNOVECTOMY AND CAPSULECTOMY WAS PERFORMED" NOTES FROM THE DISCHARGE SUMMARY: "INTRAOPERATIVE PATHOLOGY WAS OBTAINED AND THE FINDINGS WERE GROSS METALLOSIS THE TISSUE, THE HIP ABDUCTORS, HIP EXTENSORS WERE INTACT. CURRENTLY, AT THIS POINT IN TIME THE PATIENT HAS AN ILIACUS FLUID COLLECTION, WHICH WAS SLIGHTLY DECOMPRESSIVE AT THE TIME OF OPERATIVE INTERVENTION. THE PATIENT TOLERATED THE PROCEDURE WELL."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REVISION ARTHROPLASTY, RIGHT HIP.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #4IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
293182 R3 PROSTHESIS, HIP KWZ SMITH & NEPHEW ORTHOPAEDICS, LTD. * 10576
293183 * PROSTHESIS, HIP KWZ SMITH & NEPHEW SIZE 12 ECHELON PRIMARY 130MM 06EM04873
293184 * PROSTHESIS, HIP KWZ SMITH & NEPHEW * 72318
293185 * PROSTHESIS, HIP KWZ SMITH & NEPHEW +8MM 07DW11480

Patients

Seq Age Sex Outcome Treatment
1 62 YR