MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM; TIBIAL TRAY FIX CEMENTED PARTIAL

Model Number	02.18.TF2.LM
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2020: lot 160681: (b)(4) items manufactured and released on 24-oct-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 without any other similar reported event.Other devices involved in the event: moto partial knee 02.18.002lm anatomical femoral component cemented s2 lm lot.163668 (k162084).Batch review performed on 24 july 2020: lot 163668: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 2021-06-12.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.Moto partial knee 02.18.If2.09.Lm tibial insert fix s2 lm - 9mm lot.161245 (k162084).Batch review performed on 24 july 2020: lot 161245: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 2021-06-08.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
The patient came in reporting pain and the cause of the pain is unknown.The surgeon replaced the uni implants and implanted a tka 2 years and 11 months after primary.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM
• Common Device Name: TIBIAL TRAY FIX CEMENTED PARTIAL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10389664
• Report Number: 3005180920-2020-00508
• Device Sequence Number: 2259354
• Product Code: HSX
• UDI-Device Identifier: 07630030896712
• UDI-Public: 07630030896712
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: No Information
• Device Expiration Date: 05/26/2021
• Device Model Number: 02.18.TF2.LM
• Device Catalogue Number: 02.18.TF2.LM
• Device Lot Number: 160681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/11/2020
• 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