MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-02-23
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the equinoxe shoulder study that this 56 y/o male patient had a shoulder dislocation.Post op x-ray revealed shoulder was dislocated.Action taken: reduced in theatre next day.Patient was discharged in a sling on (b)(6) 2019.The case report form indicates this event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
Event or Problem Description
It was reported via clinical study, that 2 days post-operatively the patient had a shoulder dislocation.Post op x-ray revealed shoulder was dislocated.The shoulder was reduced in theatre next day.Patient was discharged in a sling.Then, approximately 3 years and 13 days post-operatively, the patient experienced instability/subluxation and underwent standard reverse revision surgery in which the standard humeral stem, torque screw, and glenoid base plate were removed.The clinical report indicates that this event is possibly related to devices and/or to the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, d6b, d10, g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(d10): concomitant device(s): 300-01-11 equinoxe, humeral stem primary, press fit 11mm.300-10-15 equinoxe replicator plate 1.5mm o/s.310-01-44 equinoxe, humeral head short, 44mm (alpha).314-02-23 uhmwpe post aug glenoid medium, left.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, d1, d4 - removal of all, d6b, h6.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via clinical study, that 12 days post-operatively of an initial left rtsa, the patient experienced a shoulder dislocation.Post-op x-ray revealed shoulder was dislocated.The shoulder was reduced in theatre next day and the outcome of this event is considered resolved.Patient was discharged in a sling.The clinical report indicates that this event is possibly related to devices and definitely related to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6 - impact code.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 definitive root cause was unable to be determined; however, may have resulted from soft tissue imbalance, rotator cuff failure, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17669421
• Report Number: 1038671-2023-02129
• Device Sequence Number: 7088224
• Product Code: KWT
• UDI-Device Identifier: 10885862175069
• UDI-Public: 10885862175069
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2025

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: 314-02-23
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/09/2024; 12/16/2024; 08/15/2025
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/30/2024; 12/18/2024; 08/19/2025
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White