MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	170-32-93
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 79 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, metal related pathology, discomfort, synovitis, and pain.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
1038671-2023-00988 d10: 120-65-20 - (b)(6) - bone screw 6.5mm dia x 20mm long 136-32-51 - (b)(6) - nv gxl lnr, +5lat, 32mm g1-48/50mm cups 164-01-11 - (b)(6) -element-stem, collarless w/ha, std offset, sz 11 180-01-50 - (b)(6) - nv crown cup clstr hole 50mm group 1 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00988.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/additional information.The following sections were corrected/added: h6: component code, type of investigation.The most likely underlying cause for the revision reported is 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).Disassociation of the liner and subsequent wear of the acetabular cup and femoral head may have been due to extensive wear of the liner or incomplete seating of the liner at the time of implantation, which allowed for unintended contact between the head and cup.However, this cannot be confirmed from the reported information, and the devices, images, and radiographs were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 21243942
• Report Number: 1038671-2025-00434
• Device Sequence Number: 17054036
• Product Code: JWH
• UDI-Device Identifier: 10885862153647
• UDI-Public: 10885862153647
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Expiration Date: 02/28/2016
• Device Catalogue Number: 170-32-93
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 03/02/2011
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female