MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 46/18; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	USP II HUMERAL HEAD 46/18
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/09/2019
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.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 through the surgical outcome system that the patient had complications related to motion loss.Additional information was obtained that the patient had an arthrex apex universe total shoulder system implanted during a (b)(6) 2018 procedure.The following devices were implanted during the (b)(6) 2018 procedure: universe apex humeral stem ar-9100-08s (lot 10070616), universe ii humeral head ar-9146-18p (lot 10129357), universe vaultlock glenoid medium ar-9106-02 (lot 1027261721) and fibertape tendon compression bridge kit with jumpstart dressing ar-7297 (lot 10197428).During patient's (b)(6) 2019 follow up with surgeon it was noted that the patient had a lack of healing of her subscapularis and has been scheduled for revision surgery on 10/9/2019.Surgeon has stated that the patient had an anatomic arthroplasty with failure of subscapularis healing.Which was not arthrex device related.A follow up will be done after the revision takes places to confirm if any arthrex products are explanted.Additional info obtained 10/2/2019: the following parts were implanted during the (b)(6) 2019 procedure: ar-9106-02, universe vaultlock glenoid medium, lot 1027261721, ar-9100-08s, universe apex humeral stem, lot 10070616, ar-9146-18p.Universe ii humeral head, lot 10129357, ar-7297, fibertape tendon compression bridge kit with jumpstart dressing, lot 10197428.Additional info obtained 10/29/2019: it has been confirmed that the patient's revision procedure took place on (b)(6) 2019.It was reported that the procedure was due to subscapularis failure and not due to implant failure.The patient was changed from an arthrex apex tsa (total shoulder) to and arthrex rsa (reverse shoulder).During the revision procedure the following original devices were explanted: ar-9106-02, universe vaultlock glenoid medium, lot 1027261721, ar-9100-08s, universe apex humeral stem, lot 10070616, ar-9146-18p.Universe ii humeral head, lot 10129357.Explanted devices were reported to have been discarded at time of procedure.

• Brand Name: USP II HUMERAL HEAD 46/18
• 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: 9353217
• Report Number: 1220246-2019-01422
• Device Sequence Number: 469772
• Product Code: KWS
• UDI-Device Identifier: 00888867057791
• UDI-Public: 00888867057791
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 03/31/2022
• Device Model Number: USP II HUMERAL HEAD 46/18
• Device Catalogue Number: AR-9146-18P
• Device Lot Number: 10129357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/21/2019
• 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