MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 6MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 6MM
Health Effect - Clinical Code	Excessive Tear Production (2235)
Date of Event	11/28/2018
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 not returned for evaluation.Per reporter the devices will not be returned.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient required a revision from an apex total shoulder that he had in (b)(6) 2017.The revision was needed due to a torn subscapular.The original devices were removed and replaced with ar-9560-24-2 and ar-9561-30s.Updated 11/29/2018: parts/lot provided by the sales rep.Original procedure surgeon was different than the revision surgeon.Both procedures were performed at the same facility.Explanted devices were as follows: ar-9100-06s, univers apex humeral stem, lot 10064881.Ar-9106-02, univers vaultlock glenoid, lot 1027261621.Ar-7298, univers spex suture kit, lot 10129987.Ar-9150-19p, usp ii humeral head, lot 160084018.

• Brand Name: UNIVERS APEX HUMERAL STEM, 6MM
• 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: 8160802
• Report Number: 1220246-2018-00803
• Device Sequence Number: 2198374
• Product Code: KWS
• UDI-Device Identifier: 00888867134416
• UDI-Public: 00888867134416
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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: 09/30/2021
• Device Model Number: UNIVERS APEX HUMERAL STEM, 6MM
• Device Catalogue Number: AR-9100-06S
• Device Lot Number: 10064881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/13/2018
• 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