MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-34
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that this female patient underwent a right total shoulder revision to convert from a tsa to a reverse tsa due to glenoid implant failure.After assessment surgeon was able to determine that the rotator cuff and subscap were intact and that revision was needed due to implant failure.The central cage on the cage glenoid remained in the vault and the glenoid implant along with the 3 peripheral pegs was dislodged from glenoid.A revision was performed and successfully converted the total shoulder to a reverse total shoulder.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (d10) concomitant device(s): 300-10-45, 5750001 - equinoxe replicator plate 4.5mm o/s 300-20-02, (b)(6)- equinox square torque define screw drive kit 310-01-44, (b)(6)- equinoxe, humeral head short, 44mm (alpha) (h3) the revision reported may have been the result of disassociation of the cage glenoid from the bone.The cause of the disassociation cannot be determined as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs were not provided.(h4) device manufacture date: 10-sep-2018 section h11: *the following sections have corrected information: (d1) brand name: equinoxe cage glenoid l, post aug, right (d4) catalog number: 314-13-34, serial number: (b)(6), expiration date: 06-sep-2023, unique identifier (udi) #: (b)(4), (d6a) if implanted, give date: (b)(6) 2019.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d5, d8, g1, g4, h6 - health effect - clinical code, medical device problem code and h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A review of manufacturing data was performed and no discrepancies were found.The revision reported may have been the result of disassociation of the cage glenoid from the bone.The cause of the disassociation cannot be determined as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16302992
• Report Number: 1038671-2023-00103
• Device Sequence Number: 6185607
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2023
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 04/22/2026
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 08/10/2023; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female