MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-03
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Joint Laxity (4526)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years and 9 months post initial left primary total should arthroplasty (tsa), the patient presented back to the doctor¿s office with complaints of pain and instability in their left shoulder.Upon radiologic examination and physical examination, it showed the patient to potentially have a loose implant and osteophyte bone growth around the glenoid.Pre-op planning software showed that the glenoid implant may have been in the incorrect position.The patient was scheduled for a revision of their primary tsa to a reverse tsa using competitor glenoid implants.During the revision, the surgeon exposed the primary total shoulder.The humeral head and replicator plate were removed.The humeral stem was tested with the stem inserted and showed the stem to be in 30 degrees of retroversion.The surgeon was satisfied with the humeral stem component position and stability.Next, the surgeon accessed the glenoid and saw that the poly implant and three peripheral pegs were floating in the joint not secured in bone.The poly and three peripheral pegs were intact and removed from the joint.The central glenoid cage was still in the glenoid vault.The glenoid cage implant was broken/disassociated from the poly implant.The surgeon used the slap hammer device to remove the cage implant.The surgeon then did a debridement and irrigation of the glenoid joint and preparation for a reverse baseplate and screws began.The competitor reverse baseplate and peripheral screws were implanted.The glenosphere was trialed and then tried to be implanted; however, the glenoid bone fractured.The implants were removed and the surgeon trialed for a hemi shoulder arthroplasty.The patient had extensive scarring and superior bone built up around the glenoid, which took extra time for dissection and removal.After the insertion of a reverse baseplate, the glenoid bone fractured.The surgeon removed the reverse implants and implanted a hemiarthroplasty.The intention was a reverse tsa; however, due to the glenoid fracturing intra-operatively, the patient was implanted with a hemi tsa.The implant was removed and the central cage of the implant was removed also.It was noted that device fragments, parts, or pieces fell into the patient but were successfully removed.The event lead to a 15-30 minute surgical delay/prolongation but the patient did not experience any adverse events as a result.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitants: 315-35-00 - glnd kwire, (b)(6); 310-01-44 - equinoxe, humeral head short, 44mm (alpha), (b)(6); 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6); 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6); 300-20-02 - equinox square torque define screw drive kit, (b)(6).

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• 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, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20819787
• Report Number: 1038671-2024-04552
• Device Sequence Number: 18105617
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 07/30/2022
• Device Catalogue Number: 314-13-03
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 07/31/2017
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 96 KG