MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID SMALL, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-02-32
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation: (d10) concomitant device(s): 310-01-44 - equinoxe, humeral head short, 44mm (alpha) 3582704.315-35-00 - glnd kwire 3661031.300-10-15 - equinoxe replicator plate 1.5mm o/s 3673699.300-20-02 - equinox square torque define screw drive kit 3730024.300-01-13 - equinoxe, humeral stem primary, press fit 13mm 3788608.321-20-00 - equinoxe reverse shoulder drill kit 3792782.
Event or Problem Description
It was reported that this patient was revised approximately 9 years 9 months post op.Reason for revision was due to rotator cuff tear leading to superior migration of the humerus.Patient went from a total shoulder arthroplasty to a reverse total shoulder arthroplasty.Surgeon left same stem insitu; removed replicator plate, all poly glenoid, torque screw and humeral head and in replacement placed a baseplate, screws, glenosphere, adaptor tray, humeral liner, reverse torque screw.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Report number: 1038671-2025-01115 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-1407-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-01115.The revision reported was likely the result of rotator cuff deterioration with subsequent superior migration of the humeral head.The reason for the rotator cuff failure cannot be conclusively determined but may be related to an underlying patient condition and/or component sizing or positioning issues.Additionally, there was observed wear on the articular surface of the glenoid.Potential contributing factors to the event such as patient activities, overstuffing of the joint, and/or soft-tissue stability cannot be assessed from the available information since the devices were not returned for evaluation and sufficient clinical information or 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 the following sections were corrected: b2 h6 the revision reported was likely the result of rotator cuff deterioration with subsequent superior migration of the humeral head.The reason for the rotator cuff failure cannot be conclusively determined but may be related to an underlying patient condition and/or component sizing or positioning issues.Additionally, there was observed wear on the articular surface of the glenoid.Potential contributing factors to the event such as patient activities, overstuffing of the joint, and/or soft-tissue stability cannot be assessed from the available information since the devices were not returned for evaluation and sufficient clinical information or 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: UHMWPE POST AUG GLENOID SMALL, RIGHT
• 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: 20613424
• Report Number: 1038671-2024-04243
• Device Sequence Number: 7553572
• Product Code: KWS
• UDI-Device Identifier: 10885862175090
• UDI-Public: 10885862175090
• 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: 2015
• 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): 02/20/2025

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: 06/13/2017
• Device Catalogue Number: 314-02-32
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 02/17/2025; 02/17/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/20/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2012
• 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; Required Intervention
• Patient Sex: Male