MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN HIP COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	170-40-93
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 6774617, 01-010-16-4195 - mono rev stem std 16x195, 2022-09.
Event or Problem Description
As reported, the female, morbidly obese patient had a revision right hip surgery for re-implantation, post-infection, on (b)(6) 2022.The patient was implanted with a competitor's acetabular component and an exactech hip monobloc stem, along with a ceramic femoral head.The patient presented back with a re-infection of the right hip post-revision surgery.The patient was scheduled for a right hip i&d and explant of hip implants on (b)(6) 2023.All implants, including the exactech revision hip stem and head, were removed and an antibiotic spacer hip implant was implanted into the patient.The patient will be monitored for infection follow-up.There is no reported breakage of devices and a 30-45 minute surgical delay/prolongation as the patient underwent extensive irrigation and debridement for infection.The patient required prolonged hospitalization as a direct result of this issue.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the cause of the patient¿s infection and subsequent revision 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, d4, d8, g4, h4, h6 - clinical code, medical device problem code, type of investigation, investigation findings, investigation conclusion and h11 a definitive root cause was unable to be determined; however, may have resulted from 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: UNKNOWN HIP COMPONENTS
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16492629
• Report Number: 1038671-2023-00376
• Device Sequence Number: 6296975
• Product Code: JDI
• UDI-Device Identifier: 10885862155535
• UDI-Public: 10885862155535
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 04/06/2026

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: 09/07/2026
• Device Model Number: 170-40-93
• Device Catalogue Number: 170-40-93
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 04/03/2026
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 07/11/2023; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female