MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.18.TF3.LM
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 160685: (b)(4) items manufactured and released on 29 october 2016.Expiration date: 2021-05-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (mdr 2017-00465).Additional implants involved: moto partial knee 02.18.003lm anatomical femoral component cemented s3 lm (k162084), lot 167863: (b)(4) items manufactured and released on 07-mar-2017.Expiration date: 2022-02-12.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any other similar reported event.Moto partial knee 02.18.If3.09.Lm tibial insert fix s3 lm - 9mm (k162084), lot 168007: (b)(4) items manufactured and released on 09-jan-2017.Expiration date: 2021-12-12.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 or Problem Description
Revision surgery performed after 1 year and 7 months from the primary due to pain (the cause of pain is unknown).The surgeon revised the moto knee to a total knee and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8560453
• Report Number: 3005180920-2019-00321
• Device Sequence Number: 1586503
• Product Code: HSX
• UDI-Device Identifier: 07630030896736
• UDI-Public: 07630030896736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2021
• Device Catalogue Number: 02.18.TF3.LM
• Device Lot Number: 160685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention