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

Catalog Number	04.01.0173
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-nov-2023: lot 2240240: 60 items manufactured and released on 28-nov-2022.Expiration date: 2027-11-16.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.Additional device involved batch review performed on 03-nov-2023: review for reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2217118: (b)(4) items manufactured and released on 10-oct-2022.Expiration date: 2027-09-20.No anomalies found related to the problem.To date, 55 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation: revision 7 months after index surgery rsa due to joint luxation.These events are normally originated by progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.From the radiographic images no additional info can be found.No further conclusion can be drawn with the elements at hand.
Event or Problem Description
Revision surgery due to joint luxation, at about 7 months after primary.The surgery has been completed successfully revising the liner and the glenosphere.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the outer chamfer of the liner shows circular scratches on the thin side of the liner that may have been caused by friction with the scapular neck.It is not possible to determine whether any early impingement may have led to instability phenomena and therefore to joint luxation.In addition, the glenosphere has a partial discoloration on the articular surface, likely due to friction with the humeral metaphysis after joint luxation.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Common Device Name: SHOULDER 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18198434
• Report Number: 3005180920-2023-00914
• Device Sequence Number: 12598958
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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 Catalogue Number: 04.01.0173
• Device Lot Number: 2240240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/23/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White