3DKNEE

Report

Report Number: 1644408-2014-00483
Event Type: Injury
Date Received: July 28, 2014
Date of Event: July 25, 2014
Report Date: July 25, 2014
Manufacturer: ENCORE MEDICAL, L.P.
Product Code: JWH
PMA / PMN Number: K020114
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REASON FOR THIS REVISION WAS INSTABILITY OF THE JOINT AFTER 5.6 YEARS OF PATIENT USE. NO INFORMATION WAS REPORTED WITH THIS COMPLAINT ABOUT ANY OTHER PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE (B)(4) COMPLAINT AGAINST LOT NUMBER 53813313. A TOTAL OF (B)(4) COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER. (B)(4) OF THE PREVIOUS INVESTIGATIONS HAVE BEEN ATTRIBUTABLE TO PATIENT JOINT INSTABILITY WITH THE REMAINDER RESULTING FROM ISSUES NOT ASSOCIATED TO LIKE EVENTS. THE ROOT CAUSE OF THIS EVENT IS SOFT TISSUE IN THE JOINT LEADING TO JOINT INSTABILITY. THERE IS NO REPORTED INFORMATION THAT INDICATES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THIS PRODUCT.

Description of Event or Problem · 1

REVISION SURGERY - DUE TO SOFT TISSUE AND INSTABILITY. THE SURGEON DECIDED TO USE A THICKER INSERT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
439196	3DKNEE	3D DCM INSERT, 9MM 4 RIGHT	JWH	ENCORE MEDICAL, L.P.		53813313

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other\| R