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

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/03/2024

Event Type  Injury  

Event 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.

Manufacturer Narrative

H3: pending investigation.D10: 7232356 170-40-00 - biolox delta femoral 40mm od, +0mm.

• Brand Name: MONO REV STEM STD 22X245
• Type of Device: 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
• MDR Text Key: 341000886
• Report Number: 1038671-2024-00968
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862282163
• UDI-Public: 10885862282163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01-010-22-4245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male