MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 10MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 10MM
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	05/17/2022
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
On (b)(6) 2022, it was reported by a sales representative via email that patient underwent a shoulder arthroplasty procedure on (b)(6) 2020.In (b)(6) 2021, patient complained of pain.On (b)(6) 2022, patient was positive for a c.Acnes infection and underwent revision surgery on (b)(6) 2022.During the revision arthroplasty surgery, an ar-9106-02 arthrex univers vaultlock glenoid, an ar-9100-10s univers apex humeral stem, and an ar-9148-19p arthrex univers ii 3d humeral head were explanted.Case was completed by implanting an antibiotic cement spacer.The original shoulder arthroplasty procedure, was performed at fox valley orthopedic associates surgery center by a different surgeon.Additional information received on 5/18/2022: all devices that were implanted on (b)(6) 2020 were explanted during revision surgery on (b)(6) 2022.After patient complaint of pain in (b)(6) of 2021, patient was monitored and revision surgery was schedule.Due to other non-orthopedic reasons, revision surgery was delayed until (b)(6) 2022.Other than the antibiotic cement spacer, no new arthrex devices were implanted during revision surgery.
Additional Manufacturer Narrative
The complaint is unable to be confirmed based on the customer-provided photos, which do not display the alleged infection or revision.No change in harm was identified.

• Brand Name: UNIVERS APEX HUMERAL STEM, 10MM
• 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: 14601955
• Report Number: 1220246-2022-05022
• Device Sequence Number: 14973562
• Product Code: KWS
• UDI-Device Identifier: 00888867134607
• UDI-Public: 00888867134607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• 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,Followup
• Report Date (Section B): 06/10/2022

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: 09/30/2024
• Device Model Number: UNIVERS APEX HUMERAL STEM, 10MM
• Device Catalogue Number: AR-9100-10S
• Device Lot Number: 10407310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/10/2022
• Date Device Manufactured: 10/11/2019
• 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