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

Model Number	GLENOID, PE WITH PEG, LARGE
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
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
It was reported that a revision surgery was performed due to a glenoid component loosening.During the revision surgery the glenoid was removed, a glenoid reconstruction using allograft was performed and shoulder prosthesis was changed to inverse.No further information received.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image provided from the field, a glenoid was explanted due to a revision surgery.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.Per dfu-0131-6, rev.0: "postoperatively, until healing is complete 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 implant.".

• Brand Name: GLENOID, PE WITH PEG, LARGE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17378856
• Report Number: 1220246-2023-07277
• Device Sequence Number: 6083405
• Product Code: KWS
• UDI-Device Identifier: 00888867057333
• UDI-Public: 00888867057333
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: GLENOID, PE WITH PEG, LARGE
• Device Catalogue Number: AR-9105-03
• Device Lot Number: 1122007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2011
• 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