FDA Adverse Event Injury Summary report: N

TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

MDR report key: 7206112 · Received January 19, 2018

Report

Report Number: 3005180920-2017-00851
Event Type: Injury
Date Received: January 19, 2018
Date of Event: December 20, 2017
Report Date: January 19, 2018
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030826535
PMA / PMN Number: K121416
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 03 JANUARY 2018: 10 MONTHS AFTER PRIMARY TKA THE PATIENT COMPLAINS OF INSTABILITY AND THE INSERT IS REPLACED TO A THICKER ONE. DEVELOPMENTAL INSTABILITY IS A POSSIBLE CONSEQUENCE OF TKA, DESCRIBED IN LITERATURE, GENERALLY DUE TO SOFT TISSUES LOSING TENSION. THE POSSIBILITY OF A VARUS ALIGNMENT AND EXCESSIVE POSTERIOR TIBIAL SLOPE MAY HAVE CONTRIBUTED TO THE SENSATION OF INSTABILITY BUT THERE IS NO SUFFICIENT DATA TO EVALUATE THIS POTENTIAL ASSOCIATION. THERE IS NO REASON TO SUSPECT A FAULTY IMPLANT AS RESPONSIBLE FOR THE PROBLEM. BATCH REVIEW PERFORMED ON 19 JANUARY 2018: LOT 161684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2016. EXPIRATION DATE: 2021-05-18 :NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

REVISION DUE TO KNEE INSTABILITY 10 MONTHS AFTER PRIMARY. POST OP X-RAYS GAVE IMPRESSION OF VARUS ALIGNMENT AND EXCESSIVE TIBIAL POSTERIOR SLOPE; IMPLANTS WELL FIXED. DURING THE SURGERY THE INSERT WAS CHANGED FROM 10MM TO 14MM ACHIEVING SATISFACTORY BALANCE AND STABILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
49093	TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L	TIBIAL INSERT FIXED	JWH	MEDACTA INTERNATIONAL SA		161684	07630030826535

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention