MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER

Model Number	04.01.0089
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
About two weeks after the previous revision surgery, the humeral head was found detached from the double eccentric.The surgeon revised the humeral head and the double eccentric and trimmed the surrounding bone by using a rongeur.The surgery was completed successfully.Patient history: primary surgery performed on (b)(6) 2025.First revision surgery performed on (b)(6) 2025 due to joint luxation; liner and glenosphere revised.Second revision surgery performed on (b)(6) 2025 due to joint luxation; liner and glenosphere revised.Third revision surgery performed on (b)(6) 2025 due to joint luxation; liner, glenosphere, and metaphysis revised.Fourth revision surgery performed on (b)(6) 2025 due joint luxation; patient converted to hemiarthroplasty - glenosphere and baseplate removed, liner and metaphysis replaced with anatomical components.This is the fifth revision surgery performed.
Additional Manufacturer Narrative
Batch review performed on 10 july 2025.Lot: 2344616: (b)(4) items manufactured and released on 23/02/2024.Expiration date: 11/02/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: revision two weeks after the previous revision surgery because detachment of the humeral head from the double eccentric was found.This could be due to the fact that the bone on the humeral tuberosity prevented the head from reaching its final position.The surgeon revised the humeral head and double eccentric and trimmed the surrounding bone using a rongeur.R&d investigation: the humeal head was reported to have disengaged from the double eccenter 10 days after a conversion from a reverse to a hemi implant.The dissociation between the two components may be associated with a potential conflict between the head and the surrounding bone (which was then removed in the revision case) during the head impaction.It is not possible to exclude the presence of soft tissues within the morse-taper that may have contributed to an incorrect engagement of the taper.No action is suggested.Other devices involved: anatomical shoulder system 04.01.0097 metal humeral head ø54 (k170910) lot: 2114060: (b)(4) items manufactured and released on 02/05/2022.Expiration date: 13/04/2027.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.The event may be attributed to patient-specific anatomical or physiological conditions (e.G., interference from adjacent bone structures or potential soft tissue interposition within the taper) that interfered with the proper seating of the components during implantation.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Additional Manufacturer Narrative
R&d investigation: the humeral head was reported to have disengaged from the double eccenter 10 days after a conversion from a reverse to a hemi implant.The humeral head ø54 lot.2114060 doesn't show any major sign of wear or usage.The morse taper interface only displays a light shade where it engages the double eccenter morse taper connector.The double eccenter (ref.(b)(4)) lot 2344616 does not display any major signs of wear or any signs of miscoupling.The double eccenter screw does not display any sign of wear, the thread is intact in all its length and no contact markings are present in its cylindrical portion.The dissociation between the two components may be associated with a potential conflict between the head and the surrounding bone (which was then removed in the revision case) during the head impaction.It is not possible to exclude the presence of soft tissues within the morse-taper that may have contributed to an incorrect engagement of the taper.No definitive root cause can be established.The conclusion remained unchanged.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22585412
• Report Number: 3005180920-2025-00663
• Device Sequence Number: 19958689
• Product Code: KWS
• UDI-Device Identifier: 07630040713122
• UDI-Public: 07630040713122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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 Model Number: 04.01.0089
• Device Lot Number: 2344616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian