MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID M, POST AUG, LEFT

Model Number	314-13-23
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Primary surgery: (b)(6) 2019.Surgeon had to do surgery on a patient with nonunion of the tub.Minus on left shoulder.He treated the nonunion without complications.While he was doing so, he realized that the poly of the glenoid was loose.The cage and two pegs where tightly connected to the bone; one peg was still connected to the poly but not integrated in the bone.The poly was sheered of the cage and the two integrated pegs.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 18-mar-2020.(d8) is this a single-use device that was reprocessed and reused on a patient?: no.(e3) occupation: physician.(g5) pma/510(k)number: k113309.(h3) the revision reported was likely the result nonunion.The reported loosening may have either been the result of drilling the peripheral peg holes at an angle or not fully seating the cage glenoid component at the time of implantation, which led to the disassociation of the metal pegs from the polyethylene body of the glenoid component.However, this cannot be confirmed because the component was not returned for evaluation and x-rays were not provided.(h4) device manufacture date: 25-mar-2015.(h6) evaluation codes: 1924, 4002 section h11: the following sections have corrected information: (h5) labeled for single use?: yes.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID M, POST AUG, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8837795
• Report Number: 1038671-2019-00378
• Device Sequence Number: 11396570
• Product Code: KWT
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 03/18/2020
• Device Model Number: 314-13-23
• Device Catalogue Number: 314-13-23
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 04/02/2020
• 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: Hospitalization; Required Intervention