MAUDE Adverse Event Report: EXACTECH, INC. MONO REV STEM STD 22X245; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	01-010-22-4245
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an original competitors total hip replacement.The patient had revision surgery on (b)(6) 2024 for metal-on-metal implant revision to poly and possible loose implants.In the first revision surgery on (b)(6) 2024 the original competitors femoral stem presented to be loose and unstable.The implant was removed and replaced with an exactech 22mmx245mm monobloc hip stem and 40mm +0mm head and a competitors poly liner in the original cup.It was noted in the revision surgery that the patient had thin proximal femoral cortices.Postoperatively the patient presented back to the surgeon's office with a hairline femur fracture to which the patient was made non-weight bearing.The patient presented back with a displaced femoral hip fracture that required revision surgery to orif.The second revision hip surgery for femoral fracture was scheduled for (b)(6) 2024.The patient was revised to a 22mmx295mm monobloc hip stem and 40mm +0mm head along with a later femoral hip different competitors fracture plate, screw, and cables.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: pending investigation.D10: 7232356 170-40-00 - biolox delta femoral 40mm od, +0mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h4, h6 mdr section codes updated/corrected: a, b, c, d, e, g the reason for the revision reported was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition and/or surgical techniques.However, this cannot be confirmed because the devices were not returned for evaluation.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 22X245
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177729
• Report Number: 1038671-2024-00968
• Device Sequence Number: 20683415
• Product Code: LZO
• UDI-Device Identifier: 10885862282163
• UDI-Public: 10885862282163
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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 Expiration Date: 10/14/2025
• Device Catalogue Number: 01-010-22-4245
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male