MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - SIZE 8; CEMENTLESS HUMERAL DIAPHYSIS

Catalog Number	04.01.0181
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2021: lot 1910850: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-03-02.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.Additional device involved: batch review performed on 22 january 2021: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452)lot.2004293: (b)(4) items manufactured and released on 09-jul-2020.Expiration date: 2025-07-07.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.Batch review performed on 22 january 2021: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452)lot.1909882: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 2025-03-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with other two similar reported events.
Event or Problem Description
Revision surgery performed due to shoulder luxation and short humeral diaphysis mobilization after about 1 month from the primary surgery date.Glenosphere, liner, metaphysis and diaphysis have been revised.

• Brand Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - SIZE 8
• Common Device Name: CEMENTLESS HUMERAL DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11214838
• Report Number: 3005180920-2021-00061
• Device Sequence Number: 4104278
• Product Code: PHX
• UDI-Device Identifier: 07630040715898
• UDI-Public: 07630040715898
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 01/22/2021

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: 03/02/2025
• Device Catalogue Number: 04.01.0181
• Device Lot Number: 1910850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/22/2021
• 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
• Patient Age: 71 YR
• Patient Weight: 72