MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø22X15; SHOULDER REVERSE SYSTEM GLENOID BASEPLATE

Catalog Number 04.01.0148

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 sept 2023: lot 2105497: (b)(4) items manufactured and released on 27-jul-2021.Expiration date: 2026-jul-08.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.Additional involved implants: batch review performed on 29 sept 2023 on reverse shoulder system 04.01.0167 glenosphere 32xø22 (k170452) lot.179964b lot 179964b: (b)(4) items manufactured and released on 13-jan-2022.Expiration date: 2027-jan-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.No anomalies have been found related to the problem on the lot of the semi-finished (glenosphere screw.) batch review performed on 29 sept 2023 on reverse shoulder system 04.01.0168 glenosphere 36xø22 (k170452) lot.2109111 lot 2109111: (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 20266-sept-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.No anomalies have been found related to the problem on the lot of the semi-finished (glenosphere screw.) batch review performed on 29 sept 2023 on reverse shoulder system 04.01.0177 glenosphere screw (k170452) lot.2215683 lot 2215683: (b)(4) items manufactured and released on 06-jul-2022.Expiration date: 2027-jun-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

During the primary shoulder surgery, it was observed that the surgeon was not able to set the glenoid onto the baseplate twice.The locking screw would not screw into glenoid baseplate ø22x15; a new locking screw was opened because the one with the glenosphere was damaged but the coupling was still not possible.The surgeon changed the baseplate to a threaded glenoid baseplate ø24.5x25 and again the locking screw would not engage the baseplate.The surgeon switched to a lat.Glenosphere 36xø24.5, changed the poly and the surgery was completed successfully.There was a 2-hour delay.A consignment set was utilized.Additional anesthesia was administered.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø22X15
• Type of Device: SHOULDER REVERSE SYSTEM GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17957400
• MDR Text Key: 325943732
• Report Number: 3005180920-2023-00806
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706353
• UDI-Public: 07630040706353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0148
• Device Lot Number: 2105497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female