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

Model Number	BIOLOX DELTA OPTION FEMORAL HEAD 36MM OD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 66 yo female patient, who had an initial right hip implanted on (b)(6), 2015, and was revised on (b)(6), 2023, underwent a second revision procedure on (b)(6), 2023.The patient presented to the surgeon due to a dislocation.They underwent a total hip acetabular revision using djo dual mobility.The patient femoral head was replaced with a sleeve and a new head to match the djo dual mobility.There were no device breakages reported.There was a 15-to-30-minute surgical delay during the procedure with no adverse event to the patient as a result.The patient was last known to be in stable condition following the event.X-rays and device images were provided.No device returns anticipated because they were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
D2b: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10: concomitants: 148-36-52 - nv ehxl 10° lnr g2 36mm, (b)(6); 170-50-00 - biolox delta adapter 16/18-12/14; +0mm, (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The revision reported was likely the result of recurrent dislocations, as reported.A secondary finding of material deformation of the acetabular liner most likely occurred due to the reported dislocation events.However, dislocation cannot be confirmed and potential contributions of user and/or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that female patient, who had an initial right (b)(6) implanted on and was revised, then underwent a second revision procedure.The patient presented to the surgeon due to a dislocation.They underwent a total hip acetabular revision using djo dual mobility.The patient femoral head was replaced with a sleeve and a new head to match the djo dual mobility.There were no device breakages reported.There was a 15-to-30-minute surgical delay during the procedure with no adverse event to the patient as a result.The patient was last known to be in stable condition following the event.X-rays and device images were provided.No device returns anticipated because they were sent to the lab and legal at the hospital.

• Brand Name: UNKNOWN HIP 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17480061
• Report Number: 1038671-2023-01903
• Device Sequence Number: 14131157
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 01/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BIOLOX DELTA OPTION FEMORAL HEAD 36MM OD
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 96 KG