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

Model Number 04.01.0174

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/16/2021

Event Type  Injury  

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 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
• Type of Device: SHOULDER REVERSE GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11320738
• MDR Text Key: 231582390
• Report Number: 3005180920-2021-00117
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2018
• 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 Age: 72 YR
• Patient Weight: 70