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

Catalog Number	314-13-14
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 86 year old male patient had an initial right tsa in (b)(6) 2016 or (b)(6) 2015.The patient was revised on (b)(6) 2024 due to wear and tear.The cage glenoid was worn out and was loose in the joint with only the cage left, which was safely removed.The poly implant was cracked and had a significant amount of cement nearly covering the back of the implant.No fragments, parts or pieces fell into the patient.Implant and pegs all removed.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Serial number, expiration and manufactured dates unknown.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loosening, and/or cracking.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not 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
Manufacturing data could not be reviewed for the anatomic glenoid component because serial number(s) were not provided, and the original surgery invoice could not be located from a search of exactech¿s surgery data.User-related considerations: there were no user-related issues reported that appear to have contributed to the reported event.Patient-related considerations: there are no patient conditions reported that appear to have contributed to the reported event.The reason for the revision reported in (b)(4) cannot be confirmed from the information provided but may be the result of prosthesis wear, loosening, and/or cracking.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not provided.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177888
• Report Number: 1038671-2024-00973
• Device Sequence Number: 15200867
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 314-13-14
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 04/14/2025; 05/22/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 04/24/2025; 05/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male