MAUDE Adverse Event Report: EXACTECH, INC. 12.5MM PLATFORM FX STEM LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	304-21-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Medical device site infection (4845); Septic loosening (4884)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-31-40 - glenosphere, 40mm, (b)(6), 320-40-03 - 145-deg pe 40mm hum liner +2.5, (b)(6), 321-52-07 - 3.2mm drill bit sterile, (b)(6), 321-52-09 - 3.2mm k-wire, trocar tip.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified there does not appear to be any remnants of bone and/or cement on the explanted fracture stem.Per the relevant ifu, ¿the cemented primary humeral stem, long/revision stem, fracture stems, and all equinoxe glenoids are intended for cemented fixation.¿ implantation of the platform fracture stem without proper application of cement may contribute to loosening of the humeral stem component; however, this cannot be confirmed from the information provided.All other components appear unremarkable for explanted devices.Instability and glenoid loosening could not be assessed as additional product images and radiographs were not provided.Operative notes and/or medical records were not provided for review of usage/ technique.A review of the sterile certificates and/or the final endotoxin test reports was performed.All lots were accepted to the requirements.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 reason for the reported revision may have been due to humeral loosening and instability as reported.Secondary findings during the revision include a potential infection and glenoid baseplate loosening.However, component loosening, infection, and instability cannot be confirmed and potential user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and relevant product images 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.
Event or Problem Description
It was reported that a male patient, who had an initial left shoulder implanted in (b)(6) 2023, underwent a revision procedure, date unknown.The patient reported loosening of the implant or instability in their affected shoulder.The plan was to extract the fx.Stem and implant a long stem, possibly use hat or hrp.While doctor was explanting, the humeral side, he noticed loosening of the glenoid baseplate and extracted everything.Dr.Determined the joint was infected and used a spacer.A competitor¿s device was used.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.It is unknown if the explanted devices will be made available at this time as it is contingent on the patient¿s approval.

• Brand Name: 12.5MM PLATFORM FX STEM LEFT
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23897047
• Report Number: 1038671-2025-03619
• Device Sequence Number: 14788485
• Product Code: KWS
• UDI-Device Identifier: 10885862083371
• UDI-Public: 10885862083371
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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 Catalogue Number: 304-21-13
• 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: 12/23/2025
• Initial Report FDA Received Date: 12/26/2025
• Date Device Manufactured: 01/06/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male