MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Catalog Number	320-02-42
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: 320-15-01, 10241308, baseplate; 320-15-05, glenosphere locking screw; 320-20-00, 98104001, torque screw; 320-10-00, 49063521, 0+ tray; 320-42-13, 42mm constrained liner; 320-20-34, 34mm screw; 320-20-30, 30mm screw; 320-20-38, 38mm screw; 320-20-34, 34mm screw; 320-20-34, 34mm screw.
Event or Problem Description
Doctor revised the shoulder but based on the bone loss, original positioning of the implant, and potential infection he was unable to repair the damage.No implants were placed in the patient.
Additional Manufacturer Narrative
Section h10: (e3) occupation: physician (g5) pma/510(k)number: k110708 (h3) it was reported that this 75 year old patient was implanted with this reverse shoulder on (b)(6) 2019, then revised on a unknown date, to a constrained because the patient was dislocating.Another surgeon revised the shoulder on (b)(6) 2019, but based on the bone loss, original positioning of the implant, and potential infection he was unable to repair any damage.No implants were placed in the patient.The patient was stable as they left the or.The devices are not returning.No further information is available.Device was used for treatment, not diagnosis.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient conditions.Corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 12-jun-2019.

• Brand Name: EQUINOXE
• Common Device Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8767837
• Report Number: 1038671-2019-00362
• Device Sequence Number: 11220713
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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 Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 58