MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 12MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 12MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/25/2019
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.It was reported that the device is no longer available to return for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via the surgical outcome system that a patient in the arthrex shoulder arthroplasty study had a right total shoulder arthroplasty procedure (b)(6) 2017.The patient was recently complained of pain and was diagnosed with loosening of the humeral prosthesis.The patient underwent a revision procedure (b)(6) 2019 during which only the humeral components of the total shoulder arthroplasty were explanted.The following arthrex devices were explanted during the 2019 procedure: ar-9156-22p humeral head (lot 160084912) and ar-9100-12s humeral stem (lot 10064889).The humeral components were replaced with another manufacturers product.At this time the disposition of the explanted devices is unknown.Additional information obtained 12/2/2019: facility has confirmed that the device is no longer available to return for evaluation.

• Brand Name: UNIVERS APEX HUMERAL STEM, 12MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9473272
• Report Number: 1220246-2019-01489
• Device Sequence Number: 3987313
• Product Code: KWS
• UDI-Device Identifier: 00888867134706
• UDI-Public: 00888867134706
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 09/30/2021
• Device Model Number: UNIVERS APEX HUMERAL STEM, 12MM
• Device Catalogue Number: AR-9100-12S
• Device Lot Number: 10064889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other