MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER,

Model Number	BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to this being related to a legal case.Concomitants: 101-45-20 - 4.5mm drill bit 20mm 5279686; 160-00-16 - pf stem tapered plasma sz 16 5533992; 170-36-93 - biolox delta femoral head 36mm od, -3.5mm 5537382; 180-65-35 - alteon 6.5mm screw, 35mm 5363986; 186-01-52 - integrip cc, cluster 52mm, g2 5543091.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
It was reported that during the investigation of a legal case, a second revision was found.A female patient, who had a left hip revision on (b)(6) 2019, underwent a revision on (b)(6) 2019, for unknown reasons.The femoral head was revised.No further information known.First revision reported under 1038671-2022-01027.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, g1, h6 - health effect - clinical code, component code, type of investigation, investigation findings and h11.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined due to insufficient information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent a hip revision.Subsequently, the patient experienced an unknown complication.As a result, the patient underwent a second revision approximately 1 year and 1 month after initial revision surgery.No further patient impact reported.No further information available.

• Brand Name: BIOLOX DELTA
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER,
• 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: ashley harris ; 3523771140
• MDR Report Key: 15635861
• Report Number: 1038671-2022-01336
• Device Sequence Number: 2809890
• Product Code: JDI
• UDI-Device Identifier: 10885862155481
• UDI-Public: 10885862155481
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 07/17/2023
• Device Model Number: BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM
• Device Catalogue Number: 170-36-93
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female