MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0003 STD HUMERAL DIAPHYSIS - CEMENTLESS - 8; SHOULDER HUMERAL DIAPHYSIS - CEMENTLESS

Model Number	04.01.0003
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 july 2022.Lot 176935: (b)(4) items manufactured and released on 13-nov-2017.Expiration date: 2022-oct-16.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.Other device involved: batch review performed on 12 july 2022.Reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot 174733: (b)(4) items manufactured and released on 26-sep-2017.Expiration date: 2022-sep-13.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 or Problem Description
Revision surgery performed 4 years after the primary surgery due to glenosphere position too superior (impingement) and stem was not stable.All implants revised.The patient already had previous revision surgery due to infection.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: revision 4 years after the primary rsa surgery in a female patient.The patient already had previous revision surgery due to infection.This may have created a difficult situation that made a superior position of the glenosphere/baseplate inevitable; a possible consequence of this could be impingement and subsequent mobilization of the humeral stem.All implants were revised.Due to the low quality of the images it is not possible to confirm if the position of the glenosphere is too superior, however, the humeral stem appears to have shifted laterally in the canal.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.In these conditions, it is very likely that due to the impingement, the stem moved from its original position and it results as shown in the radiographs.No reason to suspect faulty implants.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0003 STD HUMERAL DIAPHYSIS - CEMENTLESS - 8
• Common Device Name: SHOULDER HUMERAL DIAPHYSIS - CEMENTLESS
• 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: 15174131
• Report Number: 3005180920-2022-00584
• Device Sequence Number: 17714277
• Product Code: PHX
• UDI-Device Identifier: 07630040706025
• UDI-Public: 07630040706025
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 10/16/2022
• Device Model Number: 04.01.0003
• Device Catalogue Number: 04.01.0003
• Device Lot Number: 176935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White