MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM; UNICOMPARTIMENTAL TIBIAL TRAY

Catalog Number	02.18.TF5.LM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 november 2019: lot 160693: 61 items manufactured and released on 21-oct-2016.Expiration date: 2021-05-26.No anomalies found related to the problem.To date, 60 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: few months after primary cemented uka the anterior aspect of the tibial bone gave in and the tibial component subsided and mobilized.Reportedly, this was due to the patient's hypogonadism and poor bone quality.No reason to suspect a faulty device to be responsible for this adverse event.
Event or Problem Description
About 8 months after primary revision surgery for tibial implant subsidence.The surgery was completed successfully.All hardware revised and gmk-sphere implanted.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
• Common Device Name: UNICOMPARTIMENTAL TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9436672
• Report Number: 3005180920-2019-01041
• Device Sequence Number: 16728281
• Product Code: HSX
• UDI-Device Identifier: 07630030896774
• UDI-Public: 07630030896774
• 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: 2019
• 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): 12/09/2019

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.TF5.LM
• Device Lot Number: 160693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/09/2019
• 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