MAUDE Adverse Event Report: ARTHREX, INC. 28MM BASEPLATE, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	28MM BASEPLATE, MODULAR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a revision surgery was performed to retrieve the prosthesis.It was further reported that the defective prosthesis was caused due to the post operative actions by the patient.The patient did not follow the post op guidelines and was overloading the prosthesis too early in the gym.
Additional Manufacturer Narrative
Complaint not confirmed, the device was returned with a large chunk of bone and/or bone cement but no apparent damage or abnormality that may contributed to the event was observed.As provided in the event description, the cause of the event is likely patient non-compliance.

• Brand Name: 28MM BASEPLATE, MODULAR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11153768
• Report Number: 1220246-2021-02468
• Device Sequence Number: 3878636
• Product Code: PHX
• UDI-Device Identifier: 00888867296428
• UDI-Public: 00888867296428
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 28MM BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-28
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other