MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G2 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	140-36-52
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the 68 y/o patient had a left hip revision on (b)(6) 2023.Approximately 4 months after the revision the patient had a synovectomy on (b)(6) 2023 due to continued groin pain.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Synovectomy op report on (b)(6) 2023.Procedure: arthrotomy with synovectomy hip joint.Post-op diagnosis: polyethylene wear and osteolysis s/p left total hip arthroplasty of hip revision of (b)(6) 2023.A new mri revealed a persisting area of synovitis medially under the rectus femoris and eroding the psoas tendon.He was indicated for additional synovectomy.Initial dissection was performed medial to the rectus femoris to identify the proximal medial border of the synovial mass.Then they worked from inside the previous arthrotomy in a medial direction to identify and remove the residual synovial mass and psoas bursitis region.Removal of all of the synovial mass was assured.The patient emerged from anesthesia and was extubated in the operating before being transferred to the pacu in stable condition.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3.Investigation results-the cause of the patient¿s subsequent synovectomy cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: NV EHXL NTRL LNR G2 36MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: geoff gannon ; 3523771140
• MDR Report Key: 17181209
• Report Number: 1038671-2023-01437
• Device Sequence Number: 20448585
• Product Code: JDI
• UDI-Device Identifier: 10885862537317
• UDI-Public: 10885862537317
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 08/12/2025
• Device Model Number: 140-36-52
• Device Catalogue Number: 140-36-52
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 05/09/2024; 07/09/2026
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 05/09/2024; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male