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

Catalog Number 04.01.0155

Device Problems Fracture (1260); Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 march 2024.Lot 2209636: (b)(4) items manufactured and released on 20-sep-2022.Expiration date: 2027-aug-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Preliminary analysis performed by r&d project manager.The picture of the explants confirms that at least one screw is broken.Given the orientation of the picture, it is not possible to confirm the breakage of the second one.The failure of the bone graft resulted in the screw overloading with subsequent breakage.No action is suggested.Clinical evaluation performed by medical affairs department revision surgery 1 year and 4 months after the primary surgery due to the glenoid baseplate mobilization.According to the report, the bone graft had not osseointegrated.From the radiographic images, two glenoid polyaxial locking screws are visibly broken, almost certainly because of the graft failure to osseointegrate.The surgeon decided to graft with some iliac crest bone the glene and wait for osseointegration of this one implanting a hemiarthroplasty.Therefore, there is no reason to suspect a faulty device.Additional components involved, batch review performed on 26 march 2024: reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot.2214353 lot 2214353: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-aug-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.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot.2210985 lot 2210985: (b)(4) items manufactured and released on 12-jul-2022.Expiration date: 2027-jun-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 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot.2002442 lot 2002442: (b)(4) items manufactured and released on 07-jul-2020.Expiration date: 2025-jun-24.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 04.01.0199 glenoid polyaxial non-locking screw - l34 (k181826) lot.2217149 lot 2217149: (b)(4) items manufactured and released on 20-sep-2022.Expiration date: 2027-aug-31.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

Revision surgery performed about 1 year and 4 months after the primary surgery.The glenoid baseplate was mobilized because the bone graft had not osseointegrated.Two glenoid polyaxial locking screws were found broken.The surgeon grafted the glene with some illiac crest bone and converted into an hemi-arthroplasty.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Type of Device: 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19078274
• MDR Text Key: 339800671
• Report Number: 3005180920-2024-00205
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 2209636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2022
• 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