MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOID, PE WITH PEG, MEDIUM
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	10/17/2022
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
It was reported that a revision surgery was necessary due to a massive glenoid polyethylene loosening with loss of substance and non-contained defect of the glenoid.Due to this failure a prosthesis removal and glenoid reconstruction with allograft was necessary.No further information received.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.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 most likely cause for the reported failure can be attributed to a patient-specific event.
Event or Problem Description
On 05-july-2023, update dw: further information were provided that the revision surgery was performed on (b)(6) 2022.During the revision surgery it was found that massive glenoid polyethylene loosening with loss of substance and non-contained defect of the glenoid was found and during the revision surgery a prosthesis removal and glenoid reconstruction with allograft was performed.

• Brand Name: GLENOID, PE WITH PEG, MEDIUM
• 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: 15041987
• Report Number: 1220246-2022-05269
• Device Sequence Number: 20139821
• Product Code: KWS
• UDI-Device Identifier: 00888867057326
• UDI-Public: 00888867057326
• 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): 01/06/2025

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: 04/30/2018
• Device Model Number: GLENOID, PE WITH PEG, MEDIUM
• Device Catalogue Number: AR-9105-02
• Device Lot Number: 1321007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2013
• 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