MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6; SHOULDER HUMERAL DIAPHYSIS CEMENTLESS

Model Number	04.01.0001
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Inadequate Osseointegration (2646)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed at about 9 months after the primary surgery due to tuberosities re-absorption, which caused pain and limited rom in this patient with previous proximal humeral fracture.During the revision, mobilization of the stem was detected.The surgery was completed successfully by converting the system from anatomical to reverse and implanting a lateralized glenosphere.
Additional Manufacturer Narrative
Batch review performed on 21-oct-2022.Lot 2009918: (b)(4).Expiration date: 2026-01-27.No anomalies found related to the problem.(b)(4).Clinical evaluation performed by medical affairs department: revision performed at about 9 months after the primary surgery due to tuberosities re-absorption, which caused pain and limited rom.According to report, during the revision, mobilization of the stem was detected.Additionally, it seems from the radiographic images that the anatomical implant is smaller than the canal bone.We cannot tell if this is the result of post-surgery healing process of the bone, which may result in bone dimensional changes, or the surgeon's choice: in the latter case, no explanation for this decision was supplied.Therefore the new implant was chosen 2 sizes bigger.The anatomical implant was revised into a reverse implant with a lateralized glenosphere.Preliminary investigation performed by r&d: case of tuberosities reabsorption in a patient with previous proximal humeral fracture.Despite the implant mobilization noticed during the revision surgery, the humeral diaphysis shows signs of osseointegration on the coated region.No further comments can be made based on the information at hand.Additional components involved: anatomical shoulder system 04.01.0131 hc pegged glenoid ø46 (k170910) lot 1908966: (b)(4).Expiration date: 2025-02-01.No anomalies found related to the problem.(b)(4).Anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot 2001148: (b)(4).Expiration date: 2025-06-29.No anomalies found related to the problem.(b)(4).Anatomical shoulder system 04.01.0023 humeral anatomical metaphysis - cementless - 135° - 6 (k170910) lot 1811225: (b)(4).Expiration date: 2024-04-06.No anomalies found related to the problem.(b)(4).

• Brand Name: ANATOMICAL SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6
• Common Device Name: SHOULDER 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: 15770488
• Report Number: 3005180920-2022-00820
• Device Sequence Number: 17426378
• Product Code: PHX
• UDI-Device Identifier: 07630040706001
• UDI-Public: 07630040706001
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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: 01/27/2026
• Device Model Number: 04.01.0001
• Device Catalogue Number: 04.01.0001
• Device Lot Number: 2009918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2021
• 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