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	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 65 y/o female patient's left shoulder was revised approximately 8 months post op.Patient was trying to remove a wetsuit that was difficult to get off.She felt something give way and then had pain from this event onwards.Patient had a preserve stem tsr with a standard caged glenoid.During the revision, the metal pegs have broken off from the poly /peg interface.Everything was removed and replaced into a rtsr.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Product not returning: disposed at hospital.
Additional Manufacturer Narrative
(h3) pending evaluation: (d10) concomitant device(s): a10012 - gps implant kit v2 7025223092.310-01-44 - equinoxe, humeral head short, 44mm (alpha) 6744719.300-20-02 - equinox square torque define screw drive kit a020682.321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack a253474.300-10-15 - equinoxe replicator plate 1.5mm o/s a429288.300-30-06 - equinoxe preserve stem 6mm a632540.531-78-20 - shouldr gps hex pins kit a787435.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3: 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 manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.The investigation results concluded that the reported event occurred due to the result of the patient¿s forced movement while trying to remove a wetsuit, which led to pain, and likely caused the reported prosthesis fracture.However, this cannot be confirmed because the revised components were not returned to exactech for evaluation and no images or radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1412-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were corrected: h6.The revision reported was likely the result of the patient¿s forced movement while trying to remove a wetsuit, which led to pain, and likely caused the reported prosthesis fracture.However, this cannot be confirmed because the revised components were not returned to exactech for evaluation and no images or radiographs were 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 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20256841
• Report Number: 1038671-2024-03624
• Device Sequence Number: 15428081
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• 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: 2024
• 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,Followup,Followup
• Report Date (Section B): 02/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 12/13/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 12/19/2024; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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: 65 YR
• Patient Sex: Female