MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42XØ27; SHOULDER GLENOSPHERE

Catalog Number 04.01.0174

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

About 2 years after the primary surgery, xrays showed that the glenosphere eccentricity is upside down and that the glenosphere is dissociated from the baseplate.Revision surgery date is not defined yet.Glenosphere guide was not used during the primary surgery.

Manufacturer Narrative

Batch review performed on 27 march 2024: lot 2103684: (b)(4) items manufactured and released on 04-may-2021.Expiration date: 2026-apr-20.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.Additional device invovled: batch review performed on 27 march 2024: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot 2110377: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-nov-09.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 medacta medical affairs manager: two years after the primary surgery, the patient underwent radiographic analysis due to pain and rom decrease.From the radiographic images it is visible that the glenosphere eccentricity is upside down.The glenosphere dissociated from the baseplate.No revision surgery date is defined yet.Since the glenosphere guide was not used during the primary surgery, it may be possible that the glenosphere did not reach its final seating and with time the implant dissociated from the baseplate.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42XØ27
• Type of Device: SHOULDER GLENOSPHERE
• 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: 19151098
• MDR Text Key: 341600857
• Report Number: 3005180920-2024-00230
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 2103684
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2021
• 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): Other
• Patient Age: 83 YR
• Patient Sex: Male