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

Catalog Number	AR-9100-08S
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was discarded.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.This is the (b)(4) complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device was discarded by the facility.
Event or Problem Description
It was reported from additional information obtained on 02/09/17 that this incident occurred as a revision procedure.The patient had undergone an apex hemi arthroplasty on (b)(6) 2016 at another facility.The patient was experiencing pain and the surgeon thought the apex stem, ar-9100-08s, lot 1349710 ((b)(6) (b)(4)) was loose.During the (b)(6) 2017 revision, it was confirmed that the stem was loose.The stem and the humeral head, ar-9150-19p, lot 150058018 ((b)(6) (b)(4)) were both explanted during the revision.The case was completed by using an arthrex reverse procedure.

• 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: 6383360
• Report Number: 1220246-2017-00050
• Device Sequence Number: 13643077
• Product Code: KWS
• UDI-Device Identifier: 00888867134508
• UDI-Public: 00888867134508
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: 03/01/2020
• Device Catalogue Number: AR-9100-08S
• Device Lot Number: 1349710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/07/2017
• 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
• Patient Age: 60 YR