MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27; SHOULDER REVERSE GLENOSPHERE

Model Number	04.01.0174
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2021: lot 179115: (b)(4) items manufactured and released on 14-march-2018.Expiration date: 2023-03-05.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.Additional devices involved: batch reviews performed on 10 february 2021: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452).Lot 175035: (b)(4) items manufactured and released on 07-march-2018.Expiration date: 2023-02-26.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.Reverse shoulder system 04.01.0126 humeral reverse hc liner ø42/+3mm (k170452).Lot 179983: (b)(4) items manufactured and released on 24-april-2018.Expiration date: 2023-04-09.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452).Lot 174649: (b)(4) items manufactured and released on 06-dec-2017.Expiration date: 2022-11-28.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.Reverse shoulder system 04.01.0126 humeral reverse hc liner ø42/+3mm (k170452).Lot 179983: (b)(4) items manufactured and released on 24-april-2018.Expiration date: 2023-04-09.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.Reverse shoulder system 04.01.0182 short humeral diaphysis - cementless - 9 (k180089).Lot 182487: (b)(4) items manufactured and released on 11-may-2018.Expiration date: 2023-05-01.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.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452).Lot 174740: (b)(4) items manufactured and released on 20-dec-2017.Expiration date: 2022-12-06.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.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452).Lot 174742: (b)(4) items manufactured and released on 25-jan-2018.Expiration date: 2023-01-16.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.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452).Lot 174741: (b)(4) items manufactured and released on 11-jan-2018.Expiration date: 2022-12-28.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 or Problem Description
Revision surgery 2 years and 6 months after primary due to infection from the hematogenic source.The surgeon revised all implants.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27
• Common Device Name: SHOULDER REVERSE GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11320738
• Report Number: 3005180920-2021-00117
• Device Sequence Number: 11797365
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/12/2021

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: 03/05/2023
• Device Model Number: 04.01.0174
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 179115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/12/2021
• 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: 72 YR
• Patient Weight: 70