MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

Model Number 04.01.0110

Device Problem Unstable (1667)

Patient Problem Joint Disorder (2373)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 1906615: 206 items manufactured and released on 11-dec-2019.Expiration date: 2024-12-01.No anomalies found related to the problem.To date, 189 items of the same lot have been already sold without other similar reported event.Other devices involved in the event.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm lot.175042 (k170452) batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 175042: 160 items manufactured and released on 27-sep-2017.Expiration date: 2022-09-07.No anomalies found related to the problem.To date, 156 items of the same lot have been already sold without other similar reported event.Reverse shoulder system 04.01.0169 glenosphere 36xø24.5 lot.179109 (k170452) batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 179109: 131 items manufactured and released on 21-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, 124 items of the same lot have been already sold without other similar reported event.Reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 lot.1811893 (k170452) batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 1811893: 80 items manufactured and released on 18-lul-2019.Expiration date: 2024-07-08.No anomalies found related to the problem.To date, 43 items of the same lot have been already sold without other similar reported event.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 lot.1905799 (k170452) batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 1905799: 200 items manufactured and released on 13-aug-2019.Expiration date: 2024-07-24.No anomalies found related to the problem.To date, 154 items of the same lot have been already sold without other similar reported event.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 lot.184568 (k170452) batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 184568: 306 items manufactured and released on 25-apr-2019.Expiration date: 2024-04-10.No anomalies found related to the problem.To date, 228 items of the same lot have been already sold without other similar reported event.Reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 lot.1905798 (k170452) batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 1905798: 30 items manufactured and released on 13-aug-2019.Expiration date: 2024-07-24.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without other similar reported event.

Event Description

The patient came in reporting instability 1 month after the primary surgery and the cause of the instability is unknown.The surgeon plans to revise the poly with a thicker one.No revision has been scheduled at this time.More details to follow when the surgery occurs.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
• Type of Device: HUMERAL REVERSE METAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10366571
• MDR Text Key: 201676792
• Report Number: 3005180920-2020-00517
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

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: No Information
• Device Model Number: 04.01.0110
• Device Catalogue Number: 04.01.0110
• Device Lot Number: 1906615
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2019
• 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): Other