MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 8MM
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/19/2021, it was reported by a sales representative via email that an ar-9100-08s humeral stem and ar-9154-21p humeral head were originally implanted on (b)(6) 2019.The glenoid aspect of the surgery seemed fine both during pre-op assessment as well as intra-op.About a year and a half after implantation, patient began to experience pain and discomfort, it looked as if the stem had subsided and it was loose.During the revision surgery on (b)(6)2021, samples were taken from both the joint space and canal area.All tests came back negative for infection, which leads to the issue being aseptic loosening.Once the stem was removed there was no bony on or ingrowth in the implant.Surgeon was able to replace both humeral stem and humeral head with an ar-9501-10p revers humeral stem, an ar-9501-fx10n revers fracture adapter, and an ar-9150-19p univers humeral head.
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.

• Brand Name: UNIVERS APEX HUMERAL STEM, 8MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12954076
• Report Number: 1220246-2021-04070
• Device Sequence Number: 5409544
• Product Code: KWS
• UDI-Device Identifier: 00888867134508
• UDI-Public: 00888867134508
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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 Expiration Date: 11/30/2023
• Device Model Number: UNIVERS APEX HUMERAL STEM, 8MM
• Device Catalogue Number: AR-9100-08S
• Device Lot Number: 10264781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/07/2021
• Date Device Manufactured: 12/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown