MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, SMALL; PROSTHESIS, SHOULDER, CEMENTED

Model Number	GLENOID, PE WITH PEG, SMALL
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that after an initial eclipse surgery in (b)(6) 2013 a revision surgery of the small pegged glenoid was necessary after (b)(6) 2023 due to a glenoid loosening.No further information received.***update dw 05-aug-2024: further information was provided that the ar-9105-01 with the lot 1215007 was implanted on (b)(6) 2013.It was further reported that the glenoid loosening was diagnosed but no revision surgery took place by now.
Event or Problem Description
Update dw (b)(6) 2024: further information was provided that the ar-9105-01 with the lot 1215007 was implanted on (b)(6) 2013.It was further reported that the glenoid loosening was diagnosed but no revision surgery took place by now.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h1, h3, h6.
Event or Problem Description
Update (b)(6) 13-nov-2024: the surgeon further reported that no revision surgery was performed by now and its unlikely that a revision will be performed as the patient was rather old.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 bone encountered were not specified.The directions for use (dfu) for eclipse shoulder prothesis.D.Adverse effects.2.Allergies and other reactions to device materials.3.Loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear, or tissue reaction to the implant.Loosening is frequently a consequence of one or several of the above listed risk conditions but can also be caused by inadequate anchoring technique.E.Warnings.17.An artificial joint is subject to wear and/or can loosen over a period of time.Wear and loosening may make it necessary to re-operate on an artificial joint.H.Factors and risks impacting the safety and service life of the implant.1.Patient weight.An overweight patient may present additional risk.2.Extreme stress or strain resulting from work or sport-related activity.Based on the information provided, the most likely cause of the reported failure may be a patient-specific event, specifically the wear of the device over the passage of 10 years since the implantation surgery.

• Brand Name: GLENOID, PE WITH PEG, SMALL
• Common Device Name: PROSTHESIS, SHOULDER, 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: jared engle ; 8009337001
• MDR Report Key: 19932340
• Report Number: 1220246-2024-07080
• Device Sequence Number: 8083323
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/07/2025

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: 03/31/2017
• Device Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Device Lot Number: 1215007
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 08/02/2024; Not provided; 02/20/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/28/2024; 12/11/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown