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

Catalog Number	314-13-15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Arthropathy (4894)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years and 10 months post the initial left total shoulder arthroplasty, the patient suffered rotator cuff arthropathy and had implant damage requiring a revision to a reverse shoulder replacement.The implants were removed and a spacer was implanted.Photos provided show a fractured glenoid component.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
D10: 300-01-13 - equinoxe, humeral stem primary, press fit 13mm (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s (b)(6), 300-20-02 - equinox square torque define screw drive kit (b)(6), 310-02-50 - equinoxe, humeral head tall, 50mm (beta) (b)(6), 315-35-00 - glnd kwire (b)(6), 531-20-00 - shldr gps rvrs drill kit (b)(6), 531-78-20 - shouldr gps hex pins kit (b)(6), (b)(6) - gps implant kit v2 09000221202.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g4, h6, h11.The following sections were corrected: h6.No device was returned for evaluation; the reported event was confirmed by review of photographs of the device.The review identified that the explanted glenoid component appears to be fractured.Additionally, there does not appear to be any polyethylene remaining within the center cage, and there appears to be a circular outline in the expected location of the center cage.Based on these observations, it appears that the center cage may have fractured and subsequently worn through the glenoid body.Common causes of center cage fracture include incomplete initial seating of the glenoid component during implantation and/or off-axis drilling of the peripheral peg holes, which may result in a rocking-horse motion about a well-fixed cage.However, this cannot be confirmed as initial post-operative and pre-revision radiographs were not provided for evaluation.Based on the provided image, there does not appear to be any residual cement on the peripheral pegs.The caged glenoid is intended for cemented use.Per ifu 700-096-060 rev r, ¿the cemented primary humeral stem, long/revision stem, fracture stem, and all glenoids are intended for cemented fixation only.¿ the operative technique states, ¿cement should be placed in each of the peripheral drilled peg holes.¿ implantation of the glenoid component without proper application of cement on the peripheral pegs may contribute to a rocking horse motion around a well-fixed cage.However, this cannot be confirmed from the provided information.In addition, the patient was reported to have experienced rotator cuff arthropathy.Rotator cuff deficiencies are associated with proximal migration of the humeral component relative to the glenoid, which may result in eccentric loading and contribute to center cage fracture and/or wear around a well-fixed cage.Following the center cage fracture and subsequent wear, it is likely that continued eccentric loading and the rocking-horse motion may have contributed to fracture of the glenoid body.However, the exact sequence of events and relative contribution of each potential factor cannot be confirmed, as radiographs were not provided for evaluation.There appears to be metal debris present along the explanted glenoid component and surrounding tissue.Additionally, the center cage appears to be worn.Following the apparent center cage fracture and wear through the glenoid body, it is likely that the center cage began articulating with the humeral head, which may have resulted in the observed metal debris.However, this cannot be confirmed, as the humeral head appears unremarkable for an explanted component.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and identified that a bag used in the packaging of our polyethylene implants had been produced outside of our quality specifications.The use of these non-conforming bags may enable increased oxygen diffusion to the uhmwpe (ultra-high molecular weight polyethylene) component, resulting in increased oxidation of the material relative to components packaged with bags that conform to exactech¿s specifications.Oxidation can lead to faster device wear or failure, device component cracking or fracture, new or worsening pain, bone loss, and/or swelling in the affected area.However, oxidation index (oi) testing on uhmwpe inserts packaged in non-conforming bags showed that components with a shelf life of up to 5 years measured a maximum oi of 0.70.As described in the uhmwpe biomaterials handbook, an oi less than 1.0 is considered low and unlikely to have a substantially negative impact on mechanical behavior.All equinoxe shoulder components have a 5-year shelf life.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 rotator cuff deficiencies, prosthesis wear, and fracture of the polyethylene component.The cause of the observed center cage fracture, glenoid body fracture, and prosthesis wear cannot be definitively determined but may be related to incomplete seating of the glenoid component during implantation, off-axis drilling of the peripheral peg holes, non-cemented use during implantation, and/or proximal migration of the humeral component secondary to potential rotator cuff deficiencies, resulting in a rocking-horse motion around a well-fixed cage.However, rotator cuff deficiencies cannot be confirmed, and the potential contribution of user or patient-related factors could not be assessed, as the devices were not returned for evaluation and 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 EXTRA LARGE, BETA
• 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: 23906237
• Report Number: 1038671-2025-03626
• Device Sequence Number: 21130870
• Product Code: KWS
• UDI-Device Identifier: 10885862657961
• UDI-Public: 10885862657961
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/30/2026

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: 02/26/2023
• Device Catalogue Number: 314-13-15
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male