MAUDE Adverse Event Report: ARTHREX INC. UNIVERSAL GLENOID - BASEPLATE SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	AR-9120-01
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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.This is one of two submissions from the same event.The others are cc123986-line 205050-00357.The device is expected but has not yet been received.As reported in the event, the patient supposedly fell which dislodged the baseplate/glenosphere.The most likely cause of this event is failure to follow the post-op rehab protocol.The directions for use states: post-operatively, until healing is complete the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient had reverse total shoulder on (b)(6) 2016.The patient supposedly fell in (b)(6) which dislodged the baseplate/glenosphere.Revision surgery was completed on (b)(6) 2017, converting to hemi.**additional information received on 9/5/2017: the devices explanted during revision: ar-9120-01 lot 160012712 (line 204892), ar-9165-15nl lot 1444855 (line 205048), ar-9145-30 lot 160024110 (line 205049), ar-9504s-04 lot 160036711 (line 205050), ar-9503s-06 lot 160010209 (line 205051), ar-9145-30 lot 160009610 (line 205056).The devices implanted during the revision were ar-9950-19rca and ar-9502-36arca.Quality of bone was reported to be poor.Male, (b)(6).

• Brand Name: UNIVERSAL GLENOID - BASEPLATE SMALL
• 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: 6876269
• Report Number: 1220246-2017-00356
• Device Sequence Number: 1183366
• Product Code: KWS
• UDI-Device Identifier: 00888867057340
• UDI-Public: 00888867057340
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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 Model Number: AR-9120-01
• Device Lot Number: 160012712
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/19/2017
• 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: 62 YR