MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25; SHOULDER GLENOID BASEPLATE

Model Number 04.01.0155

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10 october 2022 on lot 2006951: (b)(4) items manufactured and released on 11-nov-2020.Expiration date: 2025-nov-02.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.Clinical evaluation performed by medical affairs department: revision surgery 1 year and 4 months after the index rsa due to glenoid components and graft mobilization, with breakage of inferior non locking screw and great bone loss around the peg.A possible reason may be due to the non integration of the graft and subsequent mobilization of the glenopshere.Subsequently, there could have been an impingement and subsequent mobilization of the humeral stem.All implants were revised.From the radiographic images, the humeral stem appears positioned 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.The surgeon put bone chips at glenoid side and switch to a hemiarthroplasty.No reason to suspect faulty implants.Preliminary analysis performed by r&d project manager: the xray confirms the failure of the bone graft and mobilization of the glenoid baseplate in the cranial direction.The breakage of the inferior screw appears to be a consequence of the implant mobilization.The pictures of the explants do not show any significant damage to the devices nor details worth a dedicated analysis.Visual inspection performed by r&d project manager: the visual inspection was carried out on monday, october 24th 2022.The glenoid baseplate shows bone residuals on the backsurface and the central post, likely due to bone remodeling and osseointegration occurred after the surgery.No further major comment can be made based on the analysis of the explants.No action is suggested.Additional involved implants: batch review performed on 10 october 2022 on reverse shoulder system 04.01.0201 glenoid polyaxial non-locking screw - l42 (k181826) lot.1908168.Lot 1908168: (b)(4) items manufactured and released on 18-dec-2019.Expiration date: 2024-dec-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.

Event Description

Revision surgery performed about 1 year and 4 months after the primary surgery due to glenoid components and graft mobilization, with breakage of inferior 42mm non locking screw and great bone loss around the peg.The surgeon put bone chips at glenoid side and switch to a hemiarthroplasty with anatomic configuration (142° and head 48).

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Type of Device: SHOULDER GLENOID BASEPLATE
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15750572
• MDR Text Key: 303226672
• Report Number: 3005180920-2022-00815
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/08/2022

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
• Device Operator: Health Professional
• Device Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 2006951
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White