MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 56MM GROUP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	BIOLOX DELTA FEMORAL HEAD 40MM OD, +7MM
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: nv ehxl alip lnr g3 40mm (cat# 142-40-63 / serial# (b)(6).Biolox delta adapter 16/18-12/14; +3.5mm (cat# 170-50-03 / serial# (b)(6).Biolox delta option femoral head 40mm od (cat# 170-40-50 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this patient was revised by surgeon due to the cup and pelvic plates failed.The cup shifted position as it lost fixation and the pelvic plate screws backed out.Patient was revised to competitor's devices.A new exactech femoral head was used.No issues with surgery.Explants not available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d6a, d4, g1, h4, h6 mdr section codes updated/corrected: a, b, c, d, e, g the reason for the revision reported was likely due to an insufficient bond between the acetabular cup and the bone, which led to migration and loosening of the cup.The patient may have had poor pelvic bone quality due to a previous fracture, which likely contributed to the acetabular loosening.However, the sequence of events cannot be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as 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: NV CROWN CUP CLSTR HOLE 56MM GROUP 3
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18395009
• Report Number: 1038671-2023-03052
• Device Sequence Number: 8724209
• Product Code: JDI
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 12/17/2016
• Device Model Number: BIOLOX DELTA FEMORAL HEAD 40MM OD, +7MM
• Device Catalogue Number: 180-01-56
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male