MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS HUMERAL STEM, 5MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	02/28/2023
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 3/1/2023, it was reported by a sales representative via email that a shoulder arthroplasty revision surgery took place on (b)(6) 2023 due to an infection.The surgeon removed an ar-9560-28 arthrex univers revers modular glenoid system modular baseplate, an ar-9502f-42lcpc arthrex univers revers suture cup, an ar-9564-2842 arthrex univers revers modular glenoid system glenosphere, an ar-9503l-03 arthrex univers revers humeral insert, (2) ar-9563-20 univers revers modular glenoid system peripheral locking screw, an ar-9562-28nl univers revers modular glenoid system peripheral non-locking screw, an ar-9562-40nl univers revers modular glenoid system peripheral non-locking screw, an ar-9561-25p univers revers modular glenoid system central post modula, and an ar-9501-05p univers revers humeral stem.
Additional Manufacturer Narrative
Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0189-9 rev 0 - warning-5.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.The most likely cause for the reported failure can be attributed to a patient-specific event.
Event or Problem Description
Additional information received on 3/1/2023: the original procedure, left reverse shoulder arthroplasty, took place on (b)(6) 2022.The case was completed successfully without any issues.About a week before the revision surgery on (b)(6) 2023, the patient presented at the office visit with redness, swelling, and drainage at the incision site, indicating an infection.A culture was taken off the infection site, and results are still pending.After removing all the implants, the surgeon placed antibiotic spacers to complete the surgery.Currently, the patient is still being treated for the infection but was discharged after the procedure was completed.

• Brand Name: UNIVERS REVERS HUMERAL STEM, 5MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 16582114
• Report Number: 1220246-2023-06449
• Device Sequence Number: 11171368
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: 00888867247628
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 02/28/2026
• Device Model Number: UNIVERS REVERS HUMERAL STEM, 5MM
• Device Catalogue Number: AR-9501-05P
• Device Lot Number: 21.00176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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