MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X35

Model Number 04.01.0153

Device Problems Material Twisted/Bent (2981); Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 12/09/2021

Event Type  Injury  

Event Description

The patient came in reporting pain due to a loose glenoid component.A revision surgery has been scheduled for (b)(6) 2021.Looking at the x-rays one polyaxial screw body seems to be bent or broken.

Manufacturer Narrative

Batch review performed on 29-nov-2021.Lot 175033: (b)(4) items manufactured and released on 17-oct-2017.Expiration date: 2022-10-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director.One year after primary tsa the glenoid component is found mobilized and one baseplate screw was broken by the mobilization process.Only pre-revision xrays are available and therefore we cannot evaluate the evolution: the baseplate appears, before revision, to be detached from the scapular bone but we cannot tell if this condition developed secondarily or if it was a choice by the surgeon at primary surgery.The distance between baseplate and bone is very likely to have created an excessive bending moment on the screws and the fracture of one of them is the consequence of this mechanical condition.With the elements at hand, we are unable to determine the root cause for this adverse event.Other devices involved: batch review performed on 29 november 2021: anatomical shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 184570: lot 184570: (b)(4) items manufactured and released on 18-dec-2018.Expiration date: 2023-12-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event on the same lot, the first case is a per-operative issue.The lot involved in this complaint is not sure given that was not revised yet.Anatomical shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 182476: (b)(4) items manufactured and released on 12 september 2018.Expiration date: 2023-08-29.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold with one similar reported event on the same lot.The lot involved in this complaint is not sure given that was not revised yet.

Manufacturer Narrative

Revision surgery was performed on (b)(6) 2021, the following information were updated: date of the event, event description, and revision date.Also, brand name was corrected and medical device problem code was added.

Event Description

The patient came in reporting pain due to a loose glenoid component and a polyaxial screw body broken.The glenoid baseplate and screws have been revised.The same mirror anatomic glenoid and humeral head were re-implanted.

• Brand Name: ANATOMICAL SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X35
• Type of Device: GLENOID BASEPLATE
• 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: 12908380
• MDR Text Key: 281512522
• Report Number: 3005180920-2021-00926
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706407
• UDI-Public: 07630040706407
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/21/2021

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: 10/05/2022
• Device Model Number: 04.01.0153
• Device Catalogue Number: 04.01.0153
• Device Lot Number: 175033
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2017
• 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 Sex: Male