MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 50/19; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number USP II HUMERAL HEAD 50/19

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Excessive Tear Production (2235)

Event Date 11/28/2018

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.Per reporter the devices will not be returned.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 required a revision from an apex total shoulder that he had in (b)(6) 2017.The revision was needed due to a torn subscapular.The original devices were removed and replaced with ar-9560-24-2 and ar-9561-30s.Updated 11/29/2018: parts/lot provided by the sales rep.Original procedure surgeon was different than the revision surgeon.Both procedures were performed at the same facility.Explanted devices were as follows: ar-9100-06s, univers apex humeral stem, lot 10064881.Ar-9106-02, univers vaultlock glenoid, lot 1027261621.Ar-7298, univers spex suture kit, lot 10129987.Ar-9150-19p, usp ii humeral head, lot 160084018.

• Brand Name: USP II HUMERAL HEAD 50/19
• 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: 8160768
• MDR Text Key: 130262439
• Report Number: 1220246-2018-00802
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057852
• UDI-Public: 00888867057852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071032
• 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: 12/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: USP II HUMERAL HEAD 50/19
• Device Catalogue Number: AR-9150-19P
• Device Lot Number: 160084018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other