MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, SIZE 5; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, SIZE 5
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On january 9th, 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) 2021, in which the arthrex univers apex implant set was used.A year later, patient complaint of pain and motion limitation.On (b)(6) 2022, a revision took place for arthroscopic debridement and nerve release of the suprascapular notch.No additional information has been reported as of now.Additional information received on 1/10/2023: the following arthrex products were implanted during the original procedure: arthrex univers ll humeral head, part number ar-9140-17p, lot170024021.Arthrex universe apex humeral stem, part number ar-9100-05s, lot 10193799.Univers vaultlock glenoid small part number ar-9106-01, lot1027262023.All remain implanted in the patient, as nothing was explanted during the revision surgery.Both surgeries were performed by the same surgeon at the same facility.
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.
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.The reported failure is most likely due to a patient-specific event.According to dfu-0131-eor3_fmt_en.D.Adverse effects.Allergies and other reactions to device materials.9.Tissue reactions caused by allergic reactions to the implanted material, particularly metal, or caused by accumulations of wear particles or cement particles.

• Brand Name: UNIVERS APEX HUMERAL STEM, SIZE 5
• 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: 16263386
• Report Number: 1220246-2023-06178
• Device Sequence Number: 11805570
• Product Code: KWS
• UDI-Device Identifier: 00888867228214
• UDI-Public: 00888867228214
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153115
• 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): 08/23/2024

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: 01/31/2023
• Device Model Number: UNIVERS APEX HUMERAL STEM, SIZE 5
• Device Catalogue Number: AR-9100-05S
• Device Lot Number: 10193799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2018
• 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