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

Model Number	UNIVERSAL GLENOID - INLAY LARGE
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	07/04/2018
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 requested but 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 by the patient that he had a shoulder surgery on (b)(6) 2014.He experienced a trauma on (b)(6) 2018.He fell on an ice plate in winter.On (b)(6) 2018 it was noticed that the pe-inlay implant broke.The implant was removed on (b)(6) 2018.A new implant was implanted on (b)(6) 2018.No further information had been made available.We do not have any information on part number / if it is an arthrex device / which customer was the operating hospital etc.Arthrex is still working on receiving further information so this incident can be evaluated.Update 08-apr-19: following devices were implanted on initial surgery: ar-9349-20 (lot.: 1295124702), ar-9301-02 (lot.: 2501338911), ar-9121-03 (lot.: 1031003), ar-9300-49cpc (2501321807).Only ar-9121-03 broke.Update 09-apr-19: it was also mentioned that due to pain in the left shoulder an arthroscopy in the left shoulder took place for control.It was not possible for the customer to tell us if those implants were arthrex devices.No part numbers or lot numbers available.But the surgeon confirmed that there was nothing wrong with the implant in the left shoulder.He cant provide us the information where the pain in the patients left shoulder comes from.

• Brand Name: UNIVERSAL GLENOID - INLAY LARGE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8566432
• Report Number: 1220246-2019-01063
• Device Sequence Number: 13862859
• Product Code: PHX
• UDI-Device Identifier: 00888867057432
• UDI-Public: 00888867057432
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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 Expiration Date: 07/31/2015
• Device Model Number: UNIVERSAL GLENOID - INLAY LARGE
• Device Catalogue Number: AR-9121-03
• Device Lot Number: 1031003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other