MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, SMALL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/07/2022
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 january 6th, 2023, a clindex notification was received indicating that a severe complication occurred of a patient listed on the shoulder arthroplasty registry.Patient underwent total shoulder procedure on (b)(6) 2020, in which the arthrex eclipse implant set was used.A year later, (b)(6) of 2022, patient presented pain and cuff dysfunction.A decision was made to convert the arthroplasty procedure to a reverse procedure on (b)(6) 2022.This is all the information provided at this time.Additional information received on 1/10/2023: during the original surgery on (b)(6) 2020, the following arthrex products were implanted: arthrex eclipse humeral head size 41x16mm, part number ar-9341-16, lot1911007.Arthrex eclipse cage screw medium, part number ar-9301-02, lot 18.01106.Arthrex eclipse trunion 39mm, part number ar-9301-39cpc lot 18.01134.Arthrex univers vault lock glenoid small, part number ar-9106-01, lot 1027261912.During the revision surgery, the following arthrex products were explanted: arthrex univers vault lock glenoid small, part number ar-9106-01, lot 1027261912.Arthrex eclipse humeral head size 41x16mm, part number ar-9341-16, lo 1911007.Arthrex eclipse cage screw medium, part number ar-9301-02, lot 18.01106.During revision surgery, the following arthrex products were implanted: modular glenoid central post, part number ar-9561-25p, lot 5436.Modular glenoid baseplate, part number ar9590-24-2, lot 14957770.Non-locking screw, part number ar9562-36n, lot number 2021005155.Locking screw, part number ar-9563-24, lot 14991605.Locking screw, part number ar-9536-16, lot number 14964000.Glenosphere, part number ar9564-t2433-lat, lot number 20.03005.Facility representative has corrected the revision surgery date to (b)(6) 2022.There was no complication while performing revision surgery.Both the original and revision surgery took place at the same facility and were performed by the same surgeon.
Additional Manufacturer Narrative
The complaint is confirmed based on the x-ray photos that the customer provided, which display the arthrex® univers vaultlock¿ glenoid, small implanted in the patient, and replaced per the pain and cuff dysfunction.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: UNIVERS VAULTLOCK GLENOID, SMALL
• 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: 16223479
• Report Number: 1220246-2023-06161
• Device Sequence Number: 5400770
• Product Code: KWS
• UDI-Device Identifier: 00888867239319
• UDI-Public: 00888867239319
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 06/30/2024
• Device Model Number: UNIVERS VAULTLOCK GLENOID, SMALL
• Device Catalogue Number: AR-9106-01
• Device Lot Number: 1027261912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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