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

Model Number	UNIVERSAL GLENOID - INLAY MEDIUM
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/31/2019
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 an eclipse surgery took place on (b)(6) 2016.According to the surgeon, the patient is very athletic and active.He is boxing and playing tennis.The patient had pain and movement restrictions after the surgery.The glenoid was conspicuous with suspicion of metal contact with the spherical cap.The surgeon decided on a revision surgery.The implants and the prosthesis were completely removed and an inverse prosthesis was implanted by another manufacturer.Unfortunately, the customer cannot give us the part number of the pe inlay.The customer has forwarded the explanted parts to a laboratory for culture testing.The laboratory discarded all parts after the testing.Following arthrex devices were explanted: ar-9120-02, ar-9121-02, cd-9347-18, ar-9300-47cpc & arthrex pe-inlay (part number unknown), it is not possible for the customer to provide us the batch numbers, no further information received.

• 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: 9409853
• Report Number: 1220246-2019-01451
• Device Sequence Number: 4130695
• 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 Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: UNIVERSAL GLENOID - INLAY MEDIUM
• Device Catalogue Number: AR-9121-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other