MAUDE Adverse Event Report: EXACTECH, INC. Biolox Knee Components; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	170-28-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Medical device site infection (4845)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left hip revision on (b)(6) 2023 and then was revised again on (b)(6) 2023 one month later for infection.The patient was admitted on (b)(6) 2023 to for infection in his left hip.Pre-op diagnosis- infection of prosthetic hip joint.Wound classification: dirty- old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera.This definition suggests that the organisms causing postoperative infection were present in the operative field before the operation.Intraoperative findings: mainly superficial fluid collection and edema about it.Some ratty tissue deep around capsule but no deep purulence.Procedure: disengaged head and liner.Stem and revision cup were well fixed.No loose screws.Patient was sent to pacu in stable condition.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H10.D10.Concomitant: a162707 - 170-50-00 - biolox delta adapter 16/18-12/14; +0mm h6.Investigation results- biolox delta option femoral head 28mm od with sn (b)(6) was properly released for use.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.The patient has bilateral hip replacements and has had multiple left hip revisions.These devices are used for treatment not diagnosis.

• Brand Name: Biolox Knee Components
• Common Device Name: 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 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa
• MDR Report Key: 18453151
• Report Number: 1038671-2024-00023
• Device Sequence Number: 18034222
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 Catalogue Number: 170-28-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Black Or African American