MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM; HUMERAL REVERSE LINER

Model Number	04.01.0121
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2022: (b)(4) items manufactured and released on 08-oct-2021.Expiration date: 2026-10-04.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: revision 1 month after rsa due to dislocation of the humeral implant from the glenosphere.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normally originated by insufficient re-establishment of soft tissue tension after the operation.Therefore, the surgeon decided to revised the implants with bigger sizes implants in order to give more tension to the soft tissues.No reason to suspect faulty implants.Additional item involved in the event, batch review performed on 17 june 2022 reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot.2101362 lot.2101362: 100 items manufactured and released on 09-june-2021.Expiration date: 2026-05-30.No anomalies found related to the problem.To date, 44 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 1 month after the primary, the patient returned for the control rx with no pain or symptoms.Dislocation of the liner from the glenosphere was detected only after x-rays.The revision surgery was performed and the surgeon revised successfully the glenosphere and insert (ø36 to ø39).

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM
• Common Device Name: HUMERAL REVERSE LINER
• 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: 14885611
• Report Number: 3005180920-2022-00502
• Device Sequence Number: 12333037
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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 Expiration Date: 10/04/2026
• Device Model Number: 04.01.0121
• Device Catalogue Number: 04.01.0121
• Device Lot Number: 2112130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2021
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White