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

Device Problem Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the patient underwent a shoulder arthroplasty procedure on (b)(6) 2017 where the following devices were implanted: ar-9100-10s lot: 10055062; ar-9106-01 lot: 1027261611 and ar-9146-20p lot: 160051618.On (b)(6) 2017, the patient underwent a revision tsa/glenoid revision and humeral head size reduction (captured on case (b)(4)) for an unknown reason and the following devices were explanted: ar-9106-01 lot: 1027261611 (medwatch 1220246-2019-00828) and ar-9146-20p lot: 160051618 (medwatch 1220246-2019-00829) and replaced with: ar-9105-01 lot: 113601629 and ar-9144-19p lot: 160047318.The patient then underwent a second revision tsa on (b)(6) 2018.Upon entering the joint space, the surgeon realized the head was barely associated to the "trunion".Moreover, the "trunion" was disassociated from the stem as well and the superior version screw was backed all the way out.Essentially the stem fell apart into 4 pieces: the screw, the head, the stem, and the "trunion".The following devices were explanted and replaced with a system from another manufacturer: ar-9100-10s lot: 10055062 (implanted during (b)(6) 2017 original procedure); ar-9105-01 lot: 113601629 (implanted during (b)(6) 2017 revision procedure) and ar-9144-19p lot: 160047318 (implanted during (b)(6) 2017 revision procedure).

• Brand Name: UNIVERS APEX HUMERAL STEM, 10MM
• Type of Device: 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: 8209505
• MDR Text Key: 131837386
• Report Number: 1220246-2019-00831
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867134607
• UDI-Public: 00888867134607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: UNIVERS APEX HUMERAL STEM, 10MM
• Device Catalogue Number: AR-9100-10S
• Device Lot Number: 10055062
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other