MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA OPTION FEMORAL HEAD 28MM OD; SEE H10

Model Number	170-28-50
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.D10.Concomitants-4681552; 170-50-93; biolox option adapter 16/18-12/14; -3.5mm.H6.Investigation results - the cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
It was reported via a legal notification that a patient, had a right hip arthroplasty revision on (b)(6), 2017 and then what is reported as re revision on an unknown date.The patient complains of pain, stiffness, discomfort, and weakness which in turn negatively affected mobility and quality of life and necessitated revision surgeries and the resultant pain following surgery and recuperation/rehabilitation period and physical therapy.The patient¿s ability to perform normal physical activities has been consequently limited.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: BIOLOX DELTA OPTION FEMORAL HEAD 28MM OD
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17371905
• Report Number: 1038671-2023-01743
• Device Sequence Number: 3784623
• Product Code: LZO
• UDI-Device Identifier: 10885862155559
• UDI-Public: 10885862155559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: 07/20/2021
• Device Model Number: 170-28-50
• Device Catalogue Number: 170-28-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/21/2023
• Date Device Manufactured: 07/21/2016
• 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 Sex: Unknown