MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

Catalog Number	04.01.0191
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 170755: 25 items manufactured and released on 27 june 2017.Expiration date: 2022-06-08 no anomalies found related to the problem.To date, 11 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on (b)(6) 2018 by medical affairs department: few months after primary rsa the metaglene is found to be loose.According to the surgeon, the initial position of the component did not allow good fixation and good function; this situation is reportedly caused by the patient's peculiar anatomy.The revision operation is very demanding and of impressive result.There is no reason to suspect that the adverse event was caused by a faulty device.
Event or Problem Description
The sales representative has been informed by the surgeon on (b)(6) 2018 that a revision surgery will be necessary.Revision surgery performed on (b)(6) 2018 due to consistent pain after about 7 months from the primary.Metaphysis, screws, glenosphere and baseplate were revised.After glenoid polyaxial screws removal the threaded glenoid baseplate was taking out very easily.
Additional Manufacturer Narrative
Additional information received on 11 july 2018: the first case was done with not medacta product and the inferior screw was implanted as requested in the st (mandatory screw).The implant mobilization and lack of osseointegration could be due to the important bone defect that it had after removing the cemented glenosphere.Visual inspection performed by r&d product manager on 14 june 2018 no sign of osseointegration was noticed on the backsurface of the threaded baseplate.This fact may have increased the risk of mobilization of the glenoid construct.The absence of osseointegration may be due to the component being originally implanted with a bone graft on a glenoid with a massive defect.The reverse surgery was indeed a revision of an anatomic implant from another company.The other inspected implants to not present details of any concern.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
• Common Device Name: THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7468345
• Report Number: 3005180920-2018-00285
• Device Sequence Number: 106770
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171058
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: 06/08/2022
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 170755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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
• Patient Age: 69 YR
• Patient Weight: 63