MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, HIP, CONSTRAINED, CEMENTED

Catalog Number	186-01-58
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported post-op via clinical study that the 46 yo male experienced a late hematogenous prosthetic joint infection that possibly developed from an upper respiratory infection, that spread through the blood stream.The event resulted in a two-stage revision, including a temporary spacer and antibiotic treatment followed by a second revision to a final implant.The outcome was last known as resolved on (b)(6)2021.
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4), category #: 170-36-00 - biolox delta femoral head 36mm od, +0mm, serial #: (b)(4), category #: 101-45-20 - 4.5mm drill bit 20mm, serial #: (b)(4), category #: 188-00-07 - wedge plasma s/o sz 7, serial #: (b)(4), category #: 140-36-53 - nv ehxl ntrl lnr g3 36mm.
Additional Manufacturer Narrative
A review of the sterile certificates and/or the final endotoxins report was performed.All lots were accepted to the requirements.The reason for the reported revision 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 #, device expiration and manufacture 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, CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; FL 32563
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 16770255
• Report Number: 1038671-2023-00751
• Device Sequence Number: 3252891
• Product Code: KWZ
• UDI-Device Identifier: 10885862038807
• UDI-Public: 10885862038807
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,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: 186-01-58
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2019
• 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; Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White