MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOSPHERE - Ø39X27

Model Number	04.01.0173
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Joint luxation occurred about 1 week after the primary surgery.Another luxation occurred two weeks after the primary surgery.About 2 weeks after the primary surgery, the patient was revised.Glenosphere size increased (diameter 42), liner +6mm and metaphysis+9mm/+20° r implanted.Patient has a bone graft.
Additional Manufacturer Narrative
Post operative ct analysis performed by r&d dept, patient matched technology dept and clinical dept.A call with the surgeon has been held to discuss the event.In addition, post-operative ct have been exanimated.The analysis of the post-op ct shows that the baseplate appears to be close to its planned position and orientation, with 4° of inferior tilt (vs.Planned 0°) and 3.5°; of retroversion (vs.5°).However, it was found to be 2.5mm more lateral than planned.This may be related to the planning that accounted for a larger compliance of the graft, that conversely did not squeeze as expected.This observation, however, cannot identify a root cause of the event.The implantation of a d 42 glenosphere (as in the revision) on the segmented baseplates as been investigated as well and a feedback to the surgeon has been provided: this solution increases the room for external rotation preventing the lever-out effect in the revision.The proposed increase in humeral torsion may also be advantageous in maximing the rom as postulated by the surgeon.As discussed during the call, surgeon's feedback on the bone graft planning have been shared to the pmt team and will be included in his future plannings.Moreover, for his future cases, pmt team will also provide a dedicated page to guide the glenoid reaming using the nextar.Batch review performed on 26 march 2026.Reverse shoulder system 04.01.0173 glenosphere - ø39x27.Lot: 2523047 (k170452): (b)(4) items manufactured and released on 10-dec-2025.Expiration date: 19-nov-2030.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.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm.Lot: 2514687 (k170452): (b)(4) items manufactured and released on 29-jul-2025.Expiration date: 08-jul-2030.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.Root cause: post-operative ct analysis showed that the baseplate position and orientation were overall consistent with the surgical plan, with minor deviations in tilt and version.A slight lateralization was observed, possibly related to differences between the planned and actual graft compliance.This finding, however, does not allow to identify a root cause for the event.The device history record review does not indicate any potentially related manufacturing issue.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE - Ø39X27
• 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: 24924657
• Report Number: 3005180920-2026-00307
• Device Sequence Number: 10299696
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/20/2026

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 Model Number: 04.01.0173
• Device Lot Number: 2523047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White