MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 10MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 10MM
Health Effect - Clinical Codes	Failure of Implant (1924); Laceration(s) (1946); Loss of Range of Motion (2032); Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a tsa procedure on (b)(6) 2019 where an arthrex ball and socket (pns unknown, pending operative report) were implanted into the patient¿s right shoulder.During the patient¿s follow up appointment, the patient complained of pain in his right shoulder and an x-ray was taken.According to the surgeon, there was nothing showing on the x-ray that was unusual.The surgeon suggested the pain was due to internal sutures in the patient¿s bicep but no further medical treatment was performed.The patient opted to see a different surgeon for the pain and in (b)(6) 2021 (exact date unknown, pending operative report), a laparoscopic procedure was performed for an internal visual.Once inside the joint, the surgeon found that the socket had exploded.He broke down the fragments and removed the fragments and cement from the tsa procedure arthroscopically¿no devices were implanted during this procedure.To date, the patient is still experiencing pain in the right shoulder as it is now ball on bone and also has a decrease in rom.The patient has seen a third surgeon who has suggested an rtsa, however, no procedure has been scheduled.Additional information provided 11/1/2021: operative reports have been provided and have been attached for both, the original tsa procedure performed on (b)(6) 2019 and the laparoscopic procedure performed on (b)(6) 2021.Requested the scrub sheet from the tsa procedure as pns were not documented on these reports.
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.

• Brand Name: UNIVERS APEX HUMERAL STEM, 10MM
• 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: 13054501
• Report Number: 1220246-2021-04137
• Device Sequence Number: 3902787
• Product Code: KWS
• UDI-Device Identifier: 00888867134607
• UDI-Public: 00888867134607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 01/31/2024
• Device Model Number: UNIVERS APEX HUMERAL STEM, 10MM
• Device Catalogue Number: AR-9100-10S
• Device Lot Number: 10280852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 12/21/2021
• Date Device Manufactured: 02/22/2019
• 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