MAUDE Adverse Event Report: EXACTECH, INC. FEMORAL COMPONENTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-36-53
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/14/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 3 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices: 2661124, 186-01-56 - integrip cc, cluster 56mm,g3 3001768 170-36-00 - biolox delta femoral head 36mm od, +0mm 3580319 164-12-10 - novation element ro x/o sz 10.The device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5, d1, d4, g1, g4, h4, h6 - health effect - clinical code, medical device problem code, component code, type of investigation and h11.Based on exactech/advita surgery data, only femoral components were billed.This suggests that only the femoral stem and head were replaced.As such, this event does not appear to be related to wear of the liner.The reason for the revision was not provided.Information regarding the reason for the revision was not provided.Due to the limited information, this complaint event cannot be further investigated or confirmed, and a definitive cause, in addition to any potential product, patient, and/or user-related contributing factors cannot be definitively determined.There is no indication within the available information that a new or unexpected failure mode or harm/adverse event type has occurred or that the benefit-risk analysis for these products has been altered; therefore, no further risk analysis will be performed.No further action or escalation will be taken at this time concerning this reported event.Should additional relevant information be received concerning this event, the complaint investigation will be re-opened and actions will be taken as appropriate.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 the patient underwent an initial total hip arthroplasty.Subsequently, the patient experienced an unknown complication.As a result, the patient underwent a hip revision approximately 2 months after initial implantation.Based on available sales data, only the femoral components were revised.No further patient impact reported.No further information available.

• Brand Name: FEMORAL COMPONENTS
• 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 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19341345
• Report Number: 1038671-2024-01306
• Device Sequence Number: 8966397
• Product Code: JDI
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• 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: 2014
• 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): 04/07/2026

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: 04/07/2019
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown