MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14; CEMENTLESS SHOULDER DIAPHYSIS

Catalog Number	04.01.0187
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review was performed on 12.August.2021: lot 1906557: 12 items manufactured and released on 11-oct-2019.Expiration date: 2024-09-28.No anomalies found related to the problem.To date, 6 items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.1908177 batch review was performed on 12.August.2021: lot 1908177: 149 items manufactured and released on 24-feb-2020.Expiration date: 2025-02-10.No anomalies found related to the problem.To date, 148 items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot.1907767 batch review was performed on 12.August.2021: lot 1907767: 56 items manufactured and released on 31-oct-2019.Expiration date: 2024-10-14.No anomalies found related to the problem.To date, 49 items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot.1908237 batch review was performed on 12.August.2021: lot 1908237: 80 items manufactured and released on 19-feb-2020.Expiration date: 2025-02-04.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot.1906607 batch review was performed on 12.August.2021: lot 1906607: 250 items manufactured and released on 11-oct-2019.Expiration date: 2024-09-23.No anomalies found related to the problem.To date, 243 items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot.1908174 batch review was performed on 12.August.2021: lot 1908174: 63 items manufactured and released on 15-jan-2020.Expiration date: 2025-01-07.No anomalies found related to the problem.To date, 61 items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0164 glenoid polyaxial locking screw - l42 (k170452) lot.184572 batch review was performed on 12.August.2021: lot 184572: 107 items manufactured and released on 25-apr-2019.Expiration date: 2024-04-10.No anomalies found related to the problem.To date, 42 items of the same lot have been sold without any similar reported event.
Event or Problem Description
1-year and 5 months after the primary surgery the surgeon revised all implants due to infection of bacteria (propionibacterium).

• Brand Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14
• Common Device Name: CEMENTLESS SHOULDER DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12406281
• Report Number: 3005180920-2021-00705
• Device Sequence Number: 14778434
• Product Code: PHX
• UDI-Device Identifier: 07630040715959
• UDI-Public: 07630040715959
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 09/28/2024
• Device Catalogue Number: 04.01.0187
• Device Lot Number: 1906557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: 81 YR