MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 48MM GROUP 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-48
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00484.Pma 510k cannot be determined; device is unknown.Product information, expiration and manufactured date unknown.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.
Event or Problem Description
It was reported that approximately 65 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, metal related pathology and pain.No further issues or complications were reported.No images were provided.No additional information is available.
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 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: NV CROWN CUP CLSTR HOLE 48MM 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
• MDR Report Key: 21471702
• Report Number: 1038671-2025-01266
• Device Sequence Number: 3567773
• Product Code: JDI
• UDI-Device Identifier: 10885862036995
• UDI-Public: 10885862036995
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 01/08/2018
• Device Catalogue Number: 180-01-48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 01/14/2013
• 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; Hospitalization
• Patient Sex: Unknown