MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27; SHOULDER GLENOSPHERE

Model Number	04.01.0211
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-mar-2021: lot 189946: (b)(4) items manufactured and released on 14-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: revision surgery performed 1 month after total shoulder arthroplasty in a (b)(6) man.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, suboptimal implant position or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.
Event or Problem Description
Revision surgery performed due to recurrent shoulder luxation (glenosphere from the liner) 1 month after the primary surgery.The patient was treated, previously, with a close reduction but the shoulder dislocated again.
Additional Manufacturer Narrative
Device returned on 26-apr-2021 and analyzed on 28-apr-2021.Visual inspection performed by r&d project manager the glenosphere and its locking screw do not present major signs of damage.The outer rim of the liner is mildly damaged, probably due to friction with the scapula after the shoulder dislocation.No action is suggested.Also, you can find below the document review of the liner involved in this event additional implant involved: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+3mm (k170452) lot.1910875.Batch review performed on 15-mar-2021.Lot: 1910875: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 18-feb-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11504347
• Report Number: 3005180920-2021-00205
• Device Sequence Number: 2843971
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/26/2021

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: 04/30/2024
• Device Model Number: 04.01.0211
• Device Catalogue Number: 04.01.0211
• Device Lot Number: 189946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 95