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

Model Number	GLENOID, PE WITH PEG, SMALL
Health Effect - Clinical Codes	Abrasion (1689); Failure of Implant (1924)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
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 too abrasion and an aseptic loosening.The shoulder prosthesis was replaced with an inverse shoulder prosthesis.No further information were provided.
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.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, 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: 12897069
• Report Number: 1220246-2021-04022
• Device Sequence Number: 17134098
• 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): 09/11/2024

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: 03/31/2020
• Device Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Device Lot Number: 1516007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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