MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number 02.18.002LM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Debris, Bone Shedding (1803)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 may 2019.Lot: 174106: (b)(4) items manufactured and released on 12-oct-2017.Expiration date: 2022-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in complaining of pain and the surgeon identified the cause of pain as patella/femoral disease 10 months after primary.The surgeon revised the uni-knee to a total-knee and during the surgery, the surgeon located a loose body laterally, bone fragment not associated with the primary surgery.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM
• Type of Device: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8631627
• MDR Text Key: 145763718
• Report Number: 3005180920-2019-00402
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895555
• UDI-Public: 07630030895555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Catalogue Number: 02.18.002LM
• Device Lot Number: 174106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention