MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA OPTION FEMORAL HEAD 36MM OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

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	Failure of Implant (1924)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, approximately 6 months postop a right hip revision, the (b)(6) y/o female patient developed laxity in her right hip.The surgeon upsized the femoral head and achieved better tension in the joint.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital threw device away.Per ifu # 700-096-018: device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces, disassociation of modular components.Osteolysis.Unintended bone fractures.Limb length discrepancy.Decreased range of motion.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 instability issues and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Concomitant medical products.Biolox delta adapter 16/18-12/14; +7mm (cat#: 170-50-07 / serial#: (b)(4)).
Event or Problem Description
As reported, approximately 6 months postop a right hip revision, the (b)(6) y/o female patient developed laxity in her right hip.The surgeon upsized the femoral head and achieved better tension in the joint.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital threw device away.

• Brand Name: BIOLOX DELTA OPTION FEMORAL HEAD 36MM OD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11445122
• Report Number: 1038671-2021-00098
• Device Sequence Number: 14456551
• Product Code: JDI
• UDI-Device Identifier: 10885862155573
• UDI-Public: 10885862155573
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 11/13/2021
• Device Model Number: BIOLOX DELTA OPTION FEMORAL HEAD 36MM OD
• Device Catalogue Number: 170-36-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 68 YR