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

Catalog Number 04.01.0110

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 28-mar-2024: lot 2003981: (b)(4) items manufactured and released on 06-may-2021.Expiration date: 2026-04-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: batch review performed on 28-mar-2024: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot 2114974a: (b)(4) items manufactured and released on 28-dec-2021.Expiration date: 2026-11-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0148 glenoid baseplate - ø22x15 (k170452) lot 2110372: (b)(4) items manufactured and released on 10-nov-2021.Expiration date: 2026-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2118700: (b)(4) items manufactured and released on 01-mar-2022.Expiration date: 2027-02-10.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2118707: (b)(4) items manufactured and released on 21-feb-2022.Expiration date: 2027-02-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Reverse shoulder system 04.01.0168 glenosphere - ø36x22 (k170452) lot 2101360: (b)(4) items manufactured and released on 09-jun-2021.Expiration date: 2026-05-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0183 short humeral diaphysis - cementless - 10 (k180089) lot 2117700: (b)(4) items manufactured and released on 05-apr-2022.Expiration date: 2027-03-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

At about 1 year and 8 months after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
• Type of Device: SHOULDER REVERSE METAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19069589
• MDR Text Key: 339677211
• Report Number: 3005180920-2024-00234
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2024

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 Catalogue Number: 04.01.0110
• Device Lot Number: 2003981
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2021
• 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