MAUDE Adverse Event Report: ARTHREX INC. GLENOID, POLY WITH KEEL, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9104-03
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/18/2018
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.The device was received and an evaluation was conducted.The complaint was not confirmed.Lot number was not provided so device history record review cannot be performed.Cannot confirm as to why the glenoid became loose.The evaluation revealed severe scrape marks and scratches noted on the glenoid.The damages observed were most likely caused during the extraction of the implant.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 originally reported that patient underwent a shoulder arthroplasty procedure in 2010.The patient's x-rays showed a loose glenoid and potential loose components of the usp ii humeral head.The surgeon performed a revision surgery on (b)(6) 2018 and removed the humeral head (ar-9152-20p, lot: 08006502, line: 233554) and the trunion, as well as the glenoid (part number unknown).The surgeon used allograft bone chips due to lack of bone on the glenoid.No glenoid was able to be implanted.The surgeon replaced the humeral head and put in a new trunion.No known infections have been reported.No further details, additional information has been requested.Follow-up investigation: the patient was experiencing discomfort that began a year prior to the revision surgery.The same surgeon performed both surgeries at the same facility.The surgeon replaced the humeral head with an ar-9152-20p, lot: 101249339 and put in a new trunion, ar-9100tk, lot: 150038811.The part number of the glenoid has been confirmed to be ar-9104-03 (lot: unknown, line 234164).

• Brand Name: GLENOID, POLY WITH KEEL, LARGE
• 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: 7540117
• Report Number: 1220246-2018-00195
• Device Sequence Number: 14062243
• Product Code: KWS
• UDI-Device Identifier: 00888867057302
• UDI-Public: 00888867057302
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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 Catalogue Number: AR-9104-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-9152-20P, HUMERAL HEAD, LOT 08006502.
• Outcome Attributed to Adverse Event: Other