MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	01-030-01-0758
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 48 year old male patient had an initial left tha on (b)(6) 2022.The patient was revised on an unknown date due to an infected total hip.The implants were removed and a spacer implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.X-rays provided.Product not returning.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 6826277 01-030-40-0736 - alt xle lnr ntrl g7 36.7242930 170-36-03 - biolox delta femoral head 36mm od, +3.5mm.6388935 190-21-08 - alt ha s noclr ext sz 8.
Additional Manufacturer Narrative
The reason for the reported surgical intervention due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.D1: corrected.D4/d6: device, serial #, udi #, expiration, occurrence and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153988
• Report Number: 1038671-2024-00924
• Device Sequence Number: 20799010
• Product Code: JDI
• UDI-Device Identifier: 10885862549228
• UDI-Public: 10885862549228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Catalogue Number: 01-030-01-0758
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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
• Patient Age: 48 YR
• Patient Sex: Male