MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS HUMERAL HEAD 48/17; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS HUMERAL HEAD 48/17
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, it was reported through the surgical outcome system that a patient experienced an adverse event undergoing a shoulder arthroplasty procedure.No additional information provided.Additional information requested.Additional information provided (b)(6) 2021: the date of the primary procedure was 09/16/2015 for a shoulder arthroplasty.This procedure took place at southern oregon orthopedic, arthrex account # (b)(4), on (b)(6) 2015.A complication was reported on 05/25/2021 and the date of the secondary procedure was on (b)(6) 2021.No additional information provided.Additional information requested.Additional information provided on (b)(6) 2021 : the date of the revision surgery was on (b)(6) 2021.The patient had pain that began about five and a half years post operative, and continued to increase affecting the qol and therefor leading to this revision.Additional information requested.Additional information provided on (b)(6) 2021 the following explanted device numbers were provided ar-9100-10s, lot#1349768, ar-9105-02, lot #1503005, ar-9148-17 lot #2501448207.
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 HUMERAL HEAD 48/17
• 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: 12954047
• Report Number: 1220246-2021-04069
• Device Sequence Number: 17495130
• Product Code: KWS
• UDI-Device Identifier: 00888867136113
• UDI-Public: 00888867136113
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K010124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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: 06/30/2019
• Device Model Number: UNIVERS HUMERAL HEAD 48/17
• Device Catalogue Number: AR-9148-17
• Device Lot Number: 2501448207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 10/27/2014
• 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