FDA Adverse Event Other Summary report: N

TURON SHOULDER

MDR report key: 2885348 · Received December 19, 2012

Report

Report Number: 1644408-2012-00667
Event Type: Other
Date Received: December 19, 2012
Date of Event: December 11, 2012
Report Date: December 11, 2012
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: KWS
PMA / PMN Number: K080402
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS A ROTATOR CUFF FAILURE AFTER (B)(6) YEARS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE EIGHTH COMPLAINT FOR THIS PART NUMBER: FOUR DUE TO STABILITY/POOR JOINT ISSUES, TWO DUE TO INFECTION, ONE DISLOCATION, AND ONE REVISION FOR SOFT TISSUE DAMAGE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE ROTATOR CUFF FAILURE WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

Description of Event or Problem · 1

REVISION SURGERY - THE PATIENT WAS CONVERTED TO A TOTAL SHOULDER ARTHROPLASTY DUE TO A ROTATOR CUFF FAILURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TURON SHOULDER	PRIMARY HUMERAL STEM	KWS	ENCORE MEDICAL, L.P.		466G1007

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention	520-01-238, LOT 190G1004\| 520-42-120, LOT 53983481\| 520-00-000, LOT 878C1003