MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY MEDIUM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERSAL GLENOID - INLAY MEDIUM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
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 in (b)(6) 2016 the initial eclipse surgery was performed on a male patient.The arthrex humeral head - ar-9349-18 and the arthrex glenoid inlay ar-9121-02 were implanted.The surgeon requested the patient to be checked after 3 years.The doctor determined that the pe inlay was abnormal.In addition, the patient also heard metallic clacking.The surgeon therefore decided on a revision surgery.The inlay and the head were removed and replaced by new devices.The laxity was good.The revision surgery was successfully completed.According to the surgeon, the male patient is athletic and regularly goes to the gym.Nevertheless, he is not excessively active.In addition the humeral head was not the issue but since it was also removed the customer wants to send the device in.
Additional Manufacturer Narrative
Complaint confirmed, the device was found to be damaged, worn and torn.Review of the x-ray provided suggest a likely cause of the damage observed is the misalignment of the humeral head.A likely cause of the metal clacking is the worn and thinned poly.

• Brand Name: UNIVERSAL GLENOID - INLAY MEDIUM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9396458
• Report Number: 1220246-2019-01443
• Device Sequence Number: 2752157
• Product Code: PHX
• UDI-Device Identifier: 00888867057425
• UDI-Public: 00888867057425
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 Model Number: UNIVERSAL GLENOID - INLAY MEDIUM
• Device Catalogue Number: AR-9121-02
• Device Lot Number: 250123203
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other