MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMKREVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27; SHOULDER SYSTEM GLENOSPHERE

Model Number	04.01.0173
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05-oct-2022: lot 2115427: (b)(4) items manufactured and released on 22-feb-2022.Expiration date: 2027-feb-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Clinical evaluation performed by medical affairs director: revision 1 month and 3 weeks after the primary rsa due to anterior dislocation.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normal originated by progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Additional component involved: batch review performed on 05-oct-2022: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2114978: (b)(4) items manufactured and released on 01-dec-2021.Expiration date: 2026-nov-15.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
At about 1 month and 3 weeks after the primary surgery, the patient came reporting pain due to anterior dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the liner and the surgery was completed successfully.

• Brand Name: GMKREVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27
• Common Device Name: SHOULDER SYSTEM GLENOSPHERE
• 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: 15698469
• Report Number: 3005180920-2022-00800
• Device Sequence Number: 6258501
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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 Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 2115427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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: Male