MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36X27; SHOULDER REVERSE GLENOSPHERE

Model Number	04.01.0172
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: a patient with multiple sclerosis and wheelchair bound got a rsa and few months later the head dislocated and was revised to a larger one, to increase stability in the difficult situation.No reason to suspect a faulty device.Batch review performed on 16 july 2021: lot 2003812: (b)(4) items manufactured and released on 24-nov-2020.Expiration date: 2025-11-02.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.Additional device involved: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.2008850: (b)(4) items manufactured and released on 12-nov-2020.Expiration date: 2025-10-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.
Event or Problem Description
Revision surgery performed 5 months after primary following instability and luxation (glenosphere dislocated from the liner).The glenosphere was changed from a 36 to a 39 to provide more stability.The patient is in a wheelchair and is affected by multiple sclerosis.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36X27
• Common Device Name: SHOULDER REVERSE GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12266810
• Report Number: 3005180920-2021-00649
• Device Sequence Number: 11856406
• Product Code: PHX
• UDI-Device Identifier: 07630040706599
• UDI-Public: 07630040706599
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• 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): 08/03/2021

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: 11/02/2025
• Device Model Number: 04.01.0172
• Device Catalogue Number: 04.01.0172
• Device Lot Number: 2003812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/03/2021
• 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: 69 YR