MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 12MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 12MM
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/26/2020
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 via the surgical outcome system that a patient had previous shoulder procedure.The patient experienced loosening of the implant on the humeral side that was unrelated to any trauma.The patient underwent a revision to a different type of arthroplasty.Patient is ongoing and improving.No further information was provided from the surgical outcome system.Further investigation is in process.Additional information obtained 4/14/20: patient underwent a right total shoulder arthroplasty and open biceps tenosis procedure on (b)(6) 2016.Patient began experiencing pain issues in (b)(6) 2018.On (b)(6) 2020 the same surgeon performed a revision procedure at the same facility.The revision procedure was an open surgery, revision to reverse replacement.Explanted part numbers are not yet known.Patient study id is (b)(6).Additional information obtained 4/22/20: the following are the implant part numbers from the original (b)(6) 2016 procedure.All of the devices listed were explanted during the revision procedure on (b)(6) 2020.The device disposition is unknown.Ar-9106-03 univers vaultlock glenoid (lot 1027261550}.Ar-9150-19p univers ii humeral head (lot 150084918}.Ar-9100-12s univers apex humeral stem (lot 10019413}.

• Brand Name: UNIVERS APEX HUMERAL STEM, 12MM
• 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: 10055609
• Report Number: 1220246-2020-01834
• Device Sequence Number: 2812775
• Product Code: KWS
• UDI-Device Identifier: 00888867134706
• UDI-Public: 00888867134706
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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 Expiration Date: 03/31/2021
• Device Model Number: UNIVERS APEX HUMERAL STEM, 12MM
• Device Catalogue Number: AR-9100-12S
• Device Lot Number: 10019413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other