MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, MEDIUM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that an eclipse total shoulder case needed a revision due to a failed rcr.There was no report of an event that caused the failure.The caller did not know the original date of surgery (stated only that it was 'years ago').The patient is male, 64 years old.The devices from the original case were removed; these were replaced with ar-9502f-39cpc, ar-9501-10p, ar-9503m-03.

• Brand Name: UNIVERS VAULTLOCK GLENOID, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11799774
• Report Number: 1220246-2021-03045
• Device Sequence Number: 4503691
• Product Code: KWS
• UDI-Device Identifier: 00888867239326
• UDI-Public: 00888867239326
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: UNIVERS VAULTLOCK GLENOID, MEDIUM
• Device Catalogue Number: AR-9106-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/10/2021
• 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: Other