MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL 40MM OD, +0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	170-40-00
Medical Device Problem Codes	Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Metal Related Pathology (4530); Bone Shedding Debris (4557)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 136-40-53 - novation gxl lnr +5 lat 40mm group 3 cups.(b)(6), 186-03-58 - integrip mh cup sz 58mm.(b)(6), 188-01-11 - wedge plasma x/o sz 11.(b)(6), 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.Multiple mdr reports were filed for this event, please see associated report: 1038671-2022-00533.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported via legal documentation that approximately 36 months after a left total hip replacement, the patient underwent left hip revision to address prosthesis wear.A post operative op report was provided.Post op diagnosis noted chronically failed total hip arthroplasty due to polyethylene wear.Intraoperatively, the surgeon observed metallosis and synovitis and fragmented polyethylene liner pieces in the joint causing the metallosis.Additionally, the surgeon observed a linear scratch on the surface of the femoral head.Both liner and femoral head components were replaced.It was noted that the patient's weight contributed to a more complex approach and positioning difficulties, intraoperatively.No surgical or this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: a, b, c, e the most likely underlying cause for the revision reported is prosthesis wear and fracture and a combination of risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: BIOLOX DELTA FEMORAL 40MM OD, +0MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21411605
• Report Number: 1038671-2025-01075
• Device Sequence Number: 9382288
• Product Code: JDI
• UDI-Device Identifier: 10885862155504
• UDI-Public: 10885862155504
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Expiration Date: 10/14/2020
• Device Catalogue Number: 170-40-00
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 10/16/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male