MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15; REVERSE GLENOID BASEPLATE

Model Number	04.01.0151
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 february 2020: lot 174274: (b)(4) items manufactured and released on 26-sep-2017.Expiration date: 2022-09-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: 2 years after rsa the glenoid components are found at rx analysis to be too superior, and loose - it is very possible that the loosening is consequent to the suboptimal position.No mention of defective components was made in the report and we have no reason to suspect defects.
Event or Problem Description
The patient came in, 2 years and 2 months after primary surgery, reporting pain.When the surgeon took an x-ray, it was observed that the baseplate was too superior and loose.The cause of the superior and loose baseplate is unknown.The surgeon revised the glenosphere, glenoid baseplate, and insert.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15
• Common Device Name: REVERSE GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9785500
• Report Number: 3005180920-2020-00124
• Device Sequence Number: 2573959
• Product Code: PHX
• UDI-Device Identifier: 07630040706384
• UDI-Public: 07630040706384
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2022
• Device Model Number: 04.01.0151
• Device Catalogue Number: 04.01.0151
• Device Lot Number: 174274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR