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

Model Number	04.01.0148
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 29 april 2020: lot 175026: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 2022-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved: batch review performed by medacta regulatory affairs department on 29 april 2020: shoulder system 04.01.0006 std humeral diaphysis - cementless - 11 (k170452).Lot 172245: (b)(4) items manufactured and released on 31-aug-2017.Expiration date: 2022-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452).Lot 174282: (b)(4) items manufactured and released on 13-nov-2017.Expiration date: 2022-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452).Lot 174647: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 2022-10-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0167 glenosphere 32xø22 (k170452).Lot 163793: (b)(4) items manufactured and released on 20-dec-2016.Expiration date: 2021-10-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0116 humeral reverse hc liner ø32/+0mm (k170452).Lot 173414: (b)(4) items manufactured and released on 21-jun-2017.Expiration date: 2022-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452).Lot 174283: (b)(4) items manufactured and released on 20-oct-2017.Expiration date: 2022-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in 2 years and 3 months after primary due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø22X15
• Common Device Name: SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10069378
• Report Number: 3005180920-2020-00283
• Device Sequence Number: 11700628
• Product Code: PHX
• UDI-Device Identifier: 07630040706353
• UDI-Public: 07630040706353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: 04.01.0148
• Device Catalogue Number: 04.01.0148
• Device Lot Number: 175026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/19/2020
• 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