MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5

Catalog Number	04.01.0170
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2018.Lot 163797: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-10-10.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.Reverse shoulder system humeral reverse hc liner ø39/+3mm (k170452).Lot 173396: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-05-29 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 medical affairs director on 10 october 2018.Dislocation of primary rsa one month after index operation in an overweight patient with a small humerus and the results of a former fracture.We can see no indication of a faulty device originating the problem.Dislocations in rsa's are a rather common adverse event, often due to progression of the disease to the soft tissues or insufficient recuperation of soft tissue tension postoperatively.
Event or Problem Description
Revision surgery performed 2 months after primary surgery due to luxation.Humerus dislocated from glenoshere.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7951005
• Report Number: 3005180920-2018-00768
• Device Sequence Number: 16509767
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 10/10/2021
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 163797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/10/2018
• 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