MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10; SHOULDER SHORT HUMERAL DIAPHYSIS CEMENTLESS

Model Number	04.01.0183
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-sep-2022: lot 2105871: (b)(4) items manufactured and released on 15-jun-2021.Expiration date: 2026-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
Directly after the primary shoulder surgery, when the patient was in post-op recovery, it was observed that the tip of the short stem broke through the lateral cortex.It has been reported that the patient had incredibly hard bone and it was difficult to insert the stem.The revision surgery was completed successfully explanting the poly, stem, and metaphysis while a standard length stem, +9 metaphysis and a plus 3 poly were implanted.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10
• Common Device Name: SHOULDER SHORT HUMERAL DIAPHYSIS CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15550761
• Report Number: 3005180920-2022-00755
• Device Sequence Number: 19532272
• Product Code: PHX
• UDI-Device Identifier: 07630040715911
• UDI-Public: 07630040715911
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 06/07/2026
• Device Model Number: 04.01.0183
• Device Catalogue Number: 04.01.0183
• Device Lot Number: 2105871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown