MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LATERAL GLENOSPHERE 39X24.5; SHOULDER LATERAL GLENOSPHERE

Model Number 04.01.0208

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 september 2021: lot 189939: (b)(4) items manufactured and released on 8-may-2019.Expiration date: 2024-apr-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 similar reported events.Additional item involved in the event, batch review performed on 21 september 2021: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot.1908972: lot 1908972: (b)(4) items manufactured and released on 7-nov-2019.Expiration date: 2024-oct-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 3 similar reported events.

Event Description

On the second day after the primary surgery, the surgeon revised the liner and the metaphysis due to instability and looseness (mdr 2021-00784).Presently, 3 weeks after the previous surgery, the patient came in due to a dislocation of the humerus from the glenosphere.The surgeon revised the baseplate, lateralized glenosphere, humeral diaphysis, reverse metaphysis, and liner.The surgery was completed successfully.).

• Brand Name: REVERSE SHOULDER SYSTEM LATERAL GLENOSPHERE 39X24.5
• Type of Device: SHOULDER LATERAL GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12630782
• MDR Text Key: 276343134
• Report Number: 3005180920-2021-00808
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 189939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2019
• 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