MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27; REVERSE SHOULDER GLENOSPHERE

Model Number 04.01.0172

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07-jan-2020: lot 174734: (b)(4) items manufactured and released on 04-jan-2018.Expiration date: 03.12.2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by medacta r&d shoulder project manager: the provided x-rays confirm that the glenosphere dissociated from the glenoid baseplate.The glenosphere screw presents mild deformation of few crests of the thread and mild surface damage on the central region and the head likely due to friction with other implants.The liner appears partially scratched, probably caused by impingement with other implants or bone after dissociation of the glenosphere.Clinical evaluation performed by medacta medical affairs director: early loss of fixation between glenosphere and baseplate in primary rsa, few months after surgery.The screw holding the glenosphere attached to the baseplate probably backed out, causing detachment and damages to the implants.This event has not been reported before, and the causes are unknown.Based on similar experiences, we could determine that one possible cause of self-unscrewing can be insufficient tightening torque applied at implantation, and this situation can be reproduced in the laboratory, but we cannot exclude that other unknown causes may also play a role.We are therefore unable to draw a definite conclusion on this case.Additional device involved batch review performed on 07-jan-2020: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot 175036: (b)(4) items manufactured and released on 14-mar-2018.Expiration date: 05-mar-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

About 7 months after primary revision surgery performed due to dissociation of the glenosphere from the glenoid baseplate, during the revision surgery metallosis has been discovered.The glenosphere, and the humeral reverse hc liner have been replaced with new implants, the glenoid baseplate was left in place.

Manufacturer Narrative

On (b)(6) 2020 we received the device, on (b)(6) 2020 we performed our analysis.Visual inspection performed by r&d project manager the visual inspection was performed on (b)(6) 2020.The reverse liner is damaged on the thin side, possibly due to friction with the scapular neck in a 145° reverse implant configuration.The glenosphere does present any signs of damage, nor metallosis.The glenosphere screw shows circular scratches on the portion normally engaging the through-hole of the glenosphere.Given the performed analysis, it is not possible to root cause the event.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27
• Type of Device: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9574062
• MDR Text Key: 196080221
• Report Number: 3005180920-2019-01131
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706599
• UDI-Public: 07630040706599
• Combination Product (y/n): N
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: 04.01.0172
• Device Catalogue Number: 04.01.0172
• Device Lot Number: 174734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention