MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 50MM GROUP 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-50
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Osteolysis (2377)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 58 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, osteolysis and pain.Revision surgery operative notes were provided.It was noted the surgeon observed scar tissue around the acetabular margin.The polyethylene was worn superiorly.Osteolytic areas superiorly were debrided.The patient was awakened and returned to recovery room in stable condition.No additional information is available.
Additional Manufacturer Narrative
D10: ((b)(6)) 188-00-04 - wedge plasma s/o sz 4.((b)(6)) 180-65-25 - alteon 6.5mm screw, 25mm.((b)(6)) 170-32-00 - biolox delta femoral head 32mm od, +0mm.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03459.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is prosthesis wear and acetabular loosening 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 50MM GROUP 1
• 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 ; 3523771140
• MDR Report Key: 21930008
• Report Number: 1038671-2025-01933
• Device Sequence Number: 15632059
• Product Code: JDI
• UDI-Device Identifier: 10885862037008
• UDI-Public: 10885862037008
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 08/23/2020
• Device Catalogue Number: 180-01-50
• 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: 05/16/2025; 05/16/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/19/2025; 05/19/2025
• Date Device Manufactured: 08/26/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female