MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 188-00-04 - wedge plasma s/o sz 4.180-65-25 - alteon 6.5mm screw, 25mm.130-32-51 - nv gxl liner neutral, 32mm id group 1 cups.180-01-50 - nv crown cup clstr hole 50mm group 1.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported by the legal brief that approximately 100 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear with signs of oxidation/yellow discoloration, pitting, cracking and delamination of the poly, osteolysis, and synovitis.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
1038671-2024-02265.1038671-2024-02268.Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-02265 and 1038671-2024-02268.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: geoff gannon
• MDR Report Key: 19656695
• Report Number: 1038671-2024-02266
• Device Sequence Number: 12420190
• Product Code: LZO
• UDI-Device Identifier: 10885862153623
• UDI-Public: 10885862153623
• Combination Product (Y/N): N
• PMA/510(K) Number: K103012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 03/24/2020
• Device Model Number: BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM
• Device Catalogue Number: 170-32-00
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2015
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female