FDA Adverse Event Injury Summary report: N

MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM

MDR report key: 8764333 · Received July 5, 2019

Report

Report Number: 3005180920-2019-00536
Event Type: Injury
Date Received: July 5, 2019
Date of Event: June 5, 2019
Report Date: July 5, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: HSX
UDI-DI: 07630030895609
PMA / PMN Number: K162084
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 17 JUNE 2019: LOT 182117: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2018. EXPIRATION DATE: 2023-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. ADDITIONAL DEVICES INVOLVED: MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM (K162084) LOT 167758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2017. EXPIRATION DATE: 2022-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. MOTO PARTIAL KNEE 02.18.IF4.08.RM TIBIAL INSERT FIX S4 RM - 8MM (K162084) LOT. 182149: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2018. EXPIRATION DATE: 2023-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD.

Description of Event or Problem · 1

THE PATIENT CAME IN COMPLAINING OF PAIN 6 MONTHS AFTER PRIMARY AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA UNI-KNEE TO ANOTHER COMPANY'S TOTAL-KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
558636	MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM	KNEE FEMORAL UNICOMPARTIMENTAL CEMENTED COMPONENT	HSX	MEDACTA INTERNATIONAL SA		182117	07630030895609

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention