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	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
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 not returned for evaluation.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 or Problem Description
It was reported that during a revision of hemi tsa to revers tsa procedure, the knob on the slap hammer, ar-9202-14, broke off on the fourth attempt following the extraction procedure steps.The broken piece was discarded.The surgeon used a bone hook retractor (non-arthrex) and a slotted mallet, ar-9231-21, from the bone prep tray to complete the extraction.The instrument broke cleanly into two pieces.Additional information provided 9/19/2018: this was a revision from a hemi arthroplasty with an arthrex apex stem and hardware.No glenoid implants.The surgery was performed because the patient fell and tore her rotator cuff a few months ago.The surgeon felt that a reverse total shoulder arthroplasty would have the best outcome for the patient.Zimmer implants were used for the reverse procedure.Additional information provided 10/2/2018: the original dos was (b)(6) 2017.The following devices were implanted during the original surgery and explanted during the revision: apex humeral stem: ar-9100-10s/10128790.Humeral head: ar-9146-18p/140107415.

• 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: 8006640
• Report Number: 1220246-2018-00716
• Device Sequence Number: 221621
• Product Code: KWS
• UDI-Device Identifier: 00888867057791
• UDI-Public: 00888867057791
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: USP II HUMERAL HEAD 46/18
• Device Catalogue Number: AR-9146-18P
• Device Lot Number: 140107415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other