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	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 may 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 with another similar event reported.Additional device involved: batch review performed on 10 may 2021: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2006593: (b)(4) items manufactured and released on 12-nov-2020.Expiration date: 2025-10-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical director: few weeks after primary rsa, reoperation is needed because there are difficulties in wound healing.The surgeon decided to remove all implants, suspecting infection.He also noticed that the suprascapularis was damaged, which probably led to dislocation.No reason to suspect a faulty device.
Event or Problem Description
The patient had several wound cleaning ( 2 or 3) due to difficult healing.After the surgery, the wound never healed and the surgeon supposes an infection, but it was not confirmed.Finally, 1,5 months after the primary surgery the surgeon revised all implants and did not implant anything.During the revision surgery it was observed that the subscapularis was damaged (it wasn't attached) a dislocation of the glenosphere from the liner was visible on the x-rays (probably due to the subscapularis damage).No trauma reported.

• 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: 11893146
• Report Number: 3005180920-2021-00438
• Device Sequence Number: 1295277
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/27/2021
• 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: 66 YR
• Patient Weight: 76