MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 8MM
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	11/28/2018
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 requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent a primary tsa procedure on her right shoulder on (b)(6) 2016.About 12 months post-op, the patient was experiencing constant pain in her shoulder.After a year of pain, she was seen by her surgeon and when an x-ray was taken, it revealed she had a fractured humerus.The surgeon decided to convert to an rtsa.The patient underwent a revision procedure on (b)(6) 2018 to convert from primary tsa to rtsa and during the case, the surgeon found that one of the feet of the "trunion" (part of ar-9100-08s) was broken and the inferior portion of the glenoid poly (ar-9105-02) was showed signs of wear.The broken foot was found secured near the rest of the "trunion".The following three devices (along with the broken foot) were explanted: ar-9100-08s / lot: 1349709.Ar-9105-02 / lot: 113601502.Ar-9144-17p / lot: 150049215.
Additional Manufacturer Narrative
Complaint confirmed.One of the two trunnion legs was found to be broken near the base.The most likely cause of failure is an impact during removal of the device and/or during an event that may be related to the humerus fracture.

• Brand Name: UNIVERS APEX HUMERAL STEM, 8MM
• 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: 8160536
• Report Number: 1220246-2018-00800
• Device Sequence Number: 16695070
• Product Code: KWS
• UDI-Device Identifier: 00888867134508
• UDI-Public: 00888867134508
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 02/29/2020
• Device Model Number: UNIVERS APEX HUMERAL STEM, 8MM
• Device Catalogue Number: AR-9100-08S
• Device Lot Number: 1349709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other