MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

Catalog Number 04.01.0169

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Disorder (2373)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 november 2019.Lot 174730: 123 items manufactured and released on 03-nov-2017.Expiration date: 2022-09-27.No anomalies found related to the problem.To date, 117 items of the same lot have been already sold without any other similar reported event.Clinical evaluation: inlay revision performed 1 year and 7 months after reverse total shoulder due to instability.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normally originated by progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Another device was involved in the event: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452).Batch review performed on 14 november 2019.Lot 173420: 112 items manufactured and released on 04-jul-2017.Expiration date: 2022-06-18.No anomalies found related to the problem.To date, 102 items of the same lot have been already sold without any other similar reported event.

Event Description

Laxity of a reverse shoulder prosthesis, the tension of deltoideus was too high.The surgeon revised inlay from 155 to 145 degree and implanted a lateralized glenosphere 1 years and 7 months after primary.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Type of Device: 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: 9394143
• MDR Text Key: 168634831
• Report Number: 3005180920-2019-01024
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• 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: 12/02/2019

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: 09/27/2022
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 174730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2017
• 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
• Patient Age: 72 YR