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

Catalog Number	314-13-24
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-62-03 stemless humeral comp integrip, cage, size 3: a880656; 310-61-53 - stemless humeral head 53mm x 20mm x beta: a229752; 319-01-32 - steinmann pin sterile 3.2mm x 178mm: a944678.
Event or Problem Description
Approximately 3 month(s) and 10 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced breakage of a component.Patient woke up with a posterior dislocation which spontaneously relocated.Decision taken to perform a revision.Plastic glenoid plate found to have sheared off underlying metal pins and be free floating in joint.In an earlier reported event, the patient experienced instability/subluxation intra-operatively and once shoulder located correctly, placed in shoulder immobilizer sling with wedge for 3 weeks in neutral rotation.The patient underwent a standard total with stemless revision with the reported removal of the glenoid, stemless humeral head, and stemless humeral cage.The outcome of this event is considered resolved and the clinical report indicates that this event is definitely related to the device(s) and possibly related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8 h6.The following sections were corrected: b2 h6.The revision reported was likely the result of prosthesis fracture due to the eccentric loading secondary to joint instability and dislocation.However, this cannot be confirmed and contributions from user or patient-related issues, soft tissue tensioning, and/or component positioning or sizing issues to the reported event could not be assessed because the components were not returned for evaluation, and sufficient clinical information, images, or 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, LEFT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20444636
• Report Number: 1038671-2024-03973
• Device Sequence Number: 12803462
• Product Code: KWS
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 314-13-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic