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 Code	Cyst(s) (1800)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
It was reported that a revision surgery was performed due to a massive glenoid loosening with glenoid cyst formation.The patient was treated with a change of shoulder the prosthesis to inverse shoulder prosthesis.No further information received.
Event or Problem Description
05-jul-2023 update dw: further information were provided that the device will be returned end auf august 2023.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation is confirmed.Due to contamination precautions, the arthrex® univers¿ glenoid poly with peg, small, was investigated visually.It is evident that there was foreign matter encrusted around the device after it was explanted.Based on the images, arthrex was able to conclude a most likely cause.Per dfu-0131g rev 8 - e warnings: "3.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.4.Detailed instructions on the use and limitations of the device should be given to the patient.5.Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure.Implant removal should be followed by adequate postoperative management." the most likely cause for the reported failure can be attributed to a patient-specific event.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17172758
• Report Number: 1220246-2023-06951
• Device Sequence Number: 12172867
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• 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): 02/21/2025

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 Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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