MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM; REVERSE HUMERAL LINER

Model Number 04.01.0119

Device Problems Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21-jul-2020: lot 1811941: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 17-feb-2024.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 implant involved: reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot.174734.Batch review performed on 21-jul-2020: lot 174734: (b)(4) items manufactured and released on 04-jan-2018.Expiration date: 03.12.2022.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold with another similar reported event due to dislocation.This is the first case reported on this lot due to metallosis.Preliminary investigation performed by r&d project manager: in the provided pictures the glenosphere presents mild scratches on the articular surface.In addition circular signs are visible on the convex backsurface of the implant close to the central hole; these signs may be due to rubbing against the baseplate peripheral screws in case of screws mobilization or incomplete seating in their dedicated seat holes.The typical anodized finishing of the glenosphere screw (dark grey coloured) appears to be partially removed, possibly due to friction with other the glenosphere.Clinical evaluation performed by medical affairs director: a few months after primary rsa a dislocation is observed and revision surgery performed.Signs of relative movement are visible on the glenosphere locking screw and on the medial face of the glenosphere itself.In the radiographs taken before revision, it appears that the glenosphere locking screw is not fully seated, or it has partially backed out, but the surgeon reports that at revision surgery it was not loose.The circular signs on the medial face of the glenosphere suggest that said face rotated and rubbed against one of the baseplate locking screws, which was probably proud from the baseplate.We cannot tell if this was the situation after primary surgery or if the screw moved laterally by some tenths of a millimeter, perhaps due to bone remodelling.A slightly proud screw would however hinder full seating of the glenosphere on the baseplate making it possible to have rotation, compatible with the signs observed on the explants.The root cause of this adverse event cannot be fully determined with the information at hand.

Event Description

Revision surgery performed due to the dislocation of the glenosphere from the liner, 10 months after the primary surgery.During the revision surgery signs of metallosis were found on the glenosphere and its locking screw.The surgeon replaced with the glenosphere and the humeral reverse hc liner 6mm.

Manufacturer Narrative

Glenosphere returned on (b)(6) 2020 and analyzed on 26-august-2020.Visual inspection performed by r&d project manager the visual inspection was performed on (b)(6) 2020.The glenosphere has mild scratches on the articular surface and circular marks on the medial spherical surface.Black stains are visible in the inner interface for the locking screw.In addition to the observations of the preliminary analysis and the clinical analysis, it has to be noted that all of these surface defects can be also attributed to the removal of the glenosphere screw (stains) and glenosphere manipulation for extraction (circular marks, scratches on the articular surface).

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM
• Type of Device: REVERSE HUMERAL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10372282
• MDR Text Key: 201835572
• Report Number: 3005180920-2020-00484
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (y/n): N
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 02/17/2024
• Device Model Number: 04.01.0119
• Device Catalogue Number: 04.01.0119
• Device Lot Number: 1811941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention