MAUDE Adverse Event Report: EXACTECH, INC. MONO REV STEM STD 14X195; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	MONO REV STEM STD 14X195
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the surgeon revised the monobloc stem, head, and liner due to the stem being broken.The surgeon removed the proximal portion by hand and then did an osteotomy and used a trephine of the stem to remove it.Surgeon used competitor's super cables to able the femur back together and implanted a competitor's stem and replaced the liner with a new novation g2 xle liner and a competitor's biolox head.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not not available for evaluation due to the doctor requested to keep them.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Added h6: component code.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 revision reported was likely the result of a femoral stem fracture.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical 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.

• Brand Name: MONO REV STEM STD 14X195
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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
• MDR Report Key: 19580059
• Report Number: 1038671-2024-02055
• Device Sequence Number: 20662307
• Product Code: LZO
• UDI-Device Identifier: 10885862281852
• UDI-Public: 10885862281852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2025

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: 12/17/2023
• Device Model Number: MONO REV STEM STD 14X195
• Device Catalogue Number: 01-010-14-4195
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 07/08/2025; 07/08/2025
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/09/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• 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: BIOLOX DELTA HEAD 36 +0.; NOVATION XLE NEUTRAL LINER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female