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

Catalog Number	314-01-13
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
As reported, the patient underwent a right initial total shoulder arthroplasty.Subsequently, the patient was revised to a cement spacer due to infection.There were some signs of wear of the poly pre-removal, as the poly was slightly loose as a result of the infection.It then damaged further when being "levered" out via on osteotome when extracted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d4, d9, d10, g4, h4, h6, h11.The following sections were corrected: d1, h6.D10: 300-01-11; 2250066 - equinoxe humeral stem, 11mm.300-10-45; 2234098 - equinoxe replicator plate, 4.5mm.300-20-02; 2231309 - equinoxe square torque define screw drive kit.310-01-47; 2296956 - equinoxe humeral head short, 47mm (beta).The complaint device was evaluated, and the reported event was not confirmed.The evaluation identified that there appears to be backside damage on the glenoid component.This appears consistent with tool marks likely created during removal.As reported, "there were some signs of wear pre-removal as the poly was slightly loose as a result of the infection.It was then damaged further when being "levered" out via an osteotome when extracted." there appears to be cement still adhered to the backside of the keeled component.There appears to be damage on the articular surface.This appears consistent with the tool damage noted, that has extended through the body of the polyethylene.Overall, there appears to be wear across the articular surface consistent with articulation with the humeral head and over 13 years of use.There appears to be minor scratching on the articular surface of the humeral head.This may have occurred during removal of the component.No allegations were made against this device.There appears to be residual bone/bone cement adhered to the surface of the stem.Additionally, there appears to be scratching and damage on the surface of the stem.This was likely created during removal and/or cleaning of the device.No allegations were made against this device.The torque screw appears unremarkable for an explanted component.No allegations were made against this device.All other aspects of the devices appear unremarkable.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 an infection with subsequent loosening of the glenoid component.The reason for the infection cannot be conclusively determined; however, it may be related to an underlying patient condition as the devices were implanted for 13 years.The observed wear on the articular surface of the glenoid component was likely the result of over 13 years of use and articulation with the humeral head.

• Brand Name: EQUINOXE GLENOID, KEELED BETA, MEDIUM
• 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: 23179150
• Report Number: 1038671-2025-02998
• Device Sequence Number: 21285946
• Product Code: KWS
• UDI-Device Identifier: 10885862657749
• UDI-Public: 10885862657749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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 Expiration Date: 02/18/2017
• Device Catalogue Number: 314-01-13
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2012
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown