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

Catalog Number	314-13-23
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient's left shoulder was revised approximately 5 years 9 months post op.Surgeon presented x rays to rep, noticing superior migration of humerus, proximal humerus/medial calcar bone loss, and glenoid dislodged.Plan to revise to rtsa.Upon exposure, replicator plate and head were removed.Upon glenoid exposure, glenoid was very loose and was pulled out with a cocher.The center cage remained but the pegs came with the poly.There was significant bone loss in the 1-2 o clock and 7 to 8 o clock positions on the glenoid face, leaving cortex with cancellous bone gone/cavitated holes.There was significant bone loss of the lesser tuberosity and some on the medial calcar, exposing some of the press fit of the stem.Stem was very well fixated.Cavitated holes were filled with dbm putty and crushed cancellous mixture.Planned to use +10 peg for reverse, drilled to depth, achieved great screw fixation and press fit of peg.Reverse shoulder arthroplasty was achieved.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) pending evaluation, (d10) concomitant device(s): 5463595 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 5511040 300-10-45 - equinoxe replicator plate 4.5mm o/s 5622301 300-20-02 - equinox square torque define screw drive kit 5647453 310-01-50 - equinoxe, humeral head short, 50mm (beta).

• Brand Name: EQUINOXE CAGE GLENOID M, 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20239707
• Report Number: 1038671-2024-03563
• Device Sequence Number: 8134606
• Product Code: KWS
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 02/06/2021
• Device Catalogue Number: 314-13-23
• 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: 09/04/2024
• Initial Report FDA Received Date: 09/17/2024
• Date Device Manufactured: 02/09/2016
• 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: Required Intervention
• Patient Sex: Male