MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LATERAL GLENOSPHERE 36X24.5

Model Number 04.01.0119

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29.03.2021: lot 189935: (b)(4) items manufactured and released on 9-may-2019.Expiration date: 2024-04-23.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.Clinical evaluation performed by medical affairs director: revision surgery performed 6 months after reverse total shoulder in an overweight patient ((b)(6) kg) due to dislocation.The components remained intact and we cannot detect any hint of a defect that led to the problem, which may have been caused by a bone fragment originated at the time of the traumatic fracture that led the patient to the index operation.These events may also be originated by progression of disease to the soft tissues, insufficient re-establishment of soft tissue tension after the operation or implant position.No further conclusion can be drawn with the elements at hand.Additional item involved in the event, batch review performed on 29.03.2021: reverse shoulder system 04.01.0119 humeral reverse hc liner ¿36/+0mm (k170452) lot.1906562.Lot 1906562: (b)(4) items manufactured and released on 32-oct-2019.Expiration date: 2024-10-12.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.

Event Description

Revision surgery performed 6 weeks after the primary due to dislocation of the glenosphere from the liner.The surgeon revised the liner, metaphysis and glenosphere.There was a posteromedial conflict with the vicious wedge which had to dislocate the prosthesis.

Manufacturer Narrative

On april 26th 2021, the device has been received.Visual inspection performed by r&d shoulder manager: the articular surface of the glenosphere is partially dull, probably due to friction with the humeral components after the shoulder dislocation.The reverse metaphysis shows bone residuals on the ha coated surface.The outer surface is partially dull, likely caused by friction with the glenosphere after the shoulder dislocation.The liner, the glenosphere screw and the reverse metaphysis screw do not present any signs of damage or scratches.

• Brand Name: REVERSE SHOULDER SYSTEM LATERAL GLENOSPHERE 36X24.5
• Type of Device: LATERAL GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11594679
• MDR Text Key: 243109992
• Report Number: 3005180920-2021-00249
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (y/n): N
• PMA/PMN Number: K193175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: 04.01.0119
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 189935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 123