MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM DOUBLE ECCENTER; DOUBLE ECCENTER ANATOMICAL SHOULDER PROSTHESIS

Model Number	04.01.0089
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-feb-2021- lot 1908183: (b)(4) items manufactured and released on 09-apr-2020.Expiration date: 2025-mar-30.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.Additional implant involved: anatomical shoulder system 04.01.0093 metal humeral head ø46 (k170910) lot.1908187- batch review performed on 08-feb-2021.Lot 1908187: (b)(4) items manufactured and released on 12-feb-2020.Expiration date: 2025-feb-02.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.Preliminary investigation performed by r&d project manager: the information at hand let presume that the taper of the double eccenter was not engaged by the humeral head dut to presence of some cement in between.No action is suggested.
Event or Problem Description
The patient came in reporting pain due to the humeral head dissociating from the double eccenter 2 weeks after the primary.The surgeon took the head out, cleaned up the area and was able to put the original head back on.The surgeon did not use any new implants.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM DOUBLE ECCENTER
• Common Device Name: DOUBLE ECCENTER ANATOMICAL SHOULDER PROSTHESIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11306024
• Report Number: 3005180920-2021-00103
• Device Sequence Number: 16987799
• Product Code: KWS
• UDI-Device Identifier: 07630040713122
• UDI-Public: 07630040713122
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 03/30/2025
• Device Model Number: 04.01.0089
• Device Catalogue Number: 04.01.0089
• Device Lot Number: 1908183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/10/2021
• 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