MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0169
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 august 2022: lot 2112749: (b)(4) items manufactured and released on 06-dec-2021.Expiration date: 2026-11-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs manager: revision 3 months after rsa in a overweight female patient due to a dislocation.From radiographic images it is visible the dislocation between the glenophere and the humeral component.According to report, the patient remained with the joint dislocated for more than one month and it is said that this caused metallosis and growth of fibrous tissue posteriorly in the joint.This did not permit to reduce the joint.During revision, the area was cleaned and the adhesions and new scar tissues were removed, a lateralized glenosphere was implanted substituting the previous implant, while the other components were substituted keeping the same sizes.Shoulder dislocation may be due to component positioning or insufficient soft tissue tensioning.Additional item involved in the event, batch review performed on 05 august 2022: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.2108190 lot 2108190: (b)(4) items manufactured and released on 30-sept-2021.Expiration date: 2026-09-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery at about 2 months from primary for shoulder dislocation (glenosphere - liner).Signs of metallosis caused by the dislocation found in the joint.The surgeon revised glenosphere, methaphysis and liner successfully.
Additional Manufacturer Narrative
The visual inspection was performed on tuesday, 30th august 2022 by medacta r&d shoulder project manager: the articular surface of the glenosphere and the outer surface of the humeral reverse metaphysis are partially polished, likely due to friction between the two implant components.The liner does not present any sign of damage.Given the information at hand, it is not possible to determine the root cause of the event.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15283226
• Report Number: 3005180920-2022-00635
• Device Sequence Number: 16717249
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 04.01.0169
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 2112749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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: Female
• Patient Weight: 90 KG