MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; HC PEGGED GLENOID Ø48

Model Number	04.01.0132
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Left shoulder revision surgery due to pain and restriction of movement about 6.5 years after the primary surgery.Osteolysis was also noted.Reverse system implanted; rotator cuff was degenerative but repairable when completing the reverse.The pe pegged glenoid was found very damaged in the posterior inferior surface (despite being found well fixed and no impingement was observed).
Additional Manufacturer Narrative
Batch review performed on 19 feb 2026.Anatomical shoulder system 04.01.0132 hc pegged glenoid d 48 (k170910) lot: 183731: (b)(4) items manufactured and released on 14-aug-2018.Expiration date: 19-jul-2023.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.Anatomical shoulder system 04.01.0095 metal humeral head d 50 (k170910) lot: 1710142: (b)(4) items manufactured and released on 24-may-2018.Expiration date: 14-may-2023.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.Anatomical shoulder system 04.01.0028 humeral anatomical metaphysis-cementless-135 & deg; -11 (k170910) lot: 1710039: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 21-may-2023.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.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot: 185295: (b)(4) items manufactured and released on 07-dec-2018.Expiration date: 25-nov-2023.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.R&d analysis: the patient underwent left shoulder revision surgery to a reverse system approximately 6.5 years after primary anatomic arthroplasty due to pain and reduced range of motion.During revision, the rotator cuff was found to be degenerative.The cemented pegged glenoid component was well positioned, well fixed, and required significant effort to remove.However, the explanted glenoid showed notable damage, including a posterior-inferior wear pattern and a & quot; chipped & quot; section that the surgical team believes was not caused during removal.No impingement was noted, but osteolysis was observed.Based on the pictures and information provided, there is no clear evidence of an implant-related defect or failure.The long duration in vivo and the well-fixed status of the glenoid suggest a time-dependent, biological, or biomechanical process.The observed osteolysis is consistent with a biologic response to particulate debris or chronic mechanical loading.Furthermore, the posterior-inferior damage may reflect patient-specific biomechanics, such as eccentric loading due to rotator cuff degeneration, rather than an inherent device issue.The event is preliminarily assessed as not implant-related, as there is no evidence of a manufacturing defect or device malfunction.The findings are most consistent with long-term, in-vivo wear and patient-specific factors.Root cause: the most likely root cause is long-term in vivo wear associated with patient-specific biomechanical factors, including rotator cuff degeneration and eccentric loading, leading to osteolysis and progressive glenoid baseplate damage.No evidence of a manufacturing defect or device malfunction was identified.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: HC PEGGED GLENOID Ø48
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24494913
• Report Number: 3005180920-2026-00181
• Device Sequence Number: 12035071
• Product Code: KWS
• UDI-Device Identifier: 07630040713276
• UDI-Public: 07630040713276
• Combination Product (Y/N): N
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 07/19/2023
• Device Model Number: 04.01.0132
• Device Lot Number: 183731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• 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