FDA Adverse Event Injury Summary report: N

GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

MDR report key: 6662718 · Received June 23, 2017

Report

Report Number: 3005180920-2017-00325
Event Type: Injury
Date Received: June 23, 2017
Date of Event: May 24, 2017
Report Date: June 23, 2017
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
PMA / PMN Number: K090988
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ON 09 JUNE 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THREE YEARS AFTER PRIMARY POSTERO-STABILIZED TKA SURGERY, THE PATIENT WAS COMPLAINING ABOUT PAIN. RADIOGRAPHIC IMAGES SHOW THE PRESENCE OF A LOOSENED INSERT FIXATION SCREW. THE SCREW WAS REMOVED AND VISUAL INSPECTION OF THE ARTICULAR SURFACES WAS PERFORMED. WE CAN ASSUME THAT ARTICULAR SURFACES WERE NOT DAMAGED AS THE SURGEON DIDN'T REPLACE ANY ADDITIONAL DEVICE. THIS EVENT MAY BE CAUSED BY INSUFFICIENT TIGHTENING TORQUE BUT THE REAL CAUSE CAN'T BE DETERMINED. BATCH REVIEW PERFORMED ON 20 JUNE 2017. LOT 121919: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 AUGUST 2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT. NOT AVAILABLE.

Description of Event or Problem · 1

THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON NOTICED THAT THE SCREW BACKED OUT OF THE POLY. THE SURGEON REMOVED THE SCREW FROM THE PATIENT BY ARTHROSCOPY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE, EXPLANTS ARE NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
445413	GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM	TIBIAL INSERT FIXED	JWH	MEDACTA INTERNATIONAL SA		121919

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention