MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME

Catalog Number	140-32-52
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial hip implanted on an unknown date, underwent a revision procedure on (b)(6), 2023.The inlay was replaced with a 142-36-62 cc inlay vitamin e, lippe, ø 36, gr.2.No further information known at this time.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
According to the information provided, the patient was revised for a 2nd time in (b)(6) 2023 due to repeated dislocation.It appears that only the acetabular liner was revised during this second revision.The dislocation reported may have been due to positioning of the components at the time of implantation, mechanical impingement, joint tensioning, or an unreported traumatic event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocations and subsequent revision cannot be conclusively determined.The dislocation reported may have been due to positioning of the components at the time of implantation, mechanical impingement, joint tensioning, or an unreported traumatic event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocations and subsequent revision cannot be conclusively determined.
Event or Problem Description
It was reported that a patient who had an initial right hip implanted in (b)(6) 2019, and had a revision in (b)(6) 2023, underwent a second revision in (b)(6) 2023 due to repeating dislocation.No further information known at this time.Initial revision reported under mdr# 1038671-2023-02873.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.The cause of the patient¿s dislocation subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue tension, implant positioning, and/or implant selection.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Dislocation and subluxation are known risks, as outlined in the ifu.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NOVATION
• Common Device Name: HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 18401562
• Report Number: 1038671-2023-03061
• Device Sequence Number: 3968084
• Product Code: OQI
• UDI-Device Identifier: 10885862537270
• UDI-Public: 10885862537270
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 140-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 07/23/2024; 02/16/2026
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 11/05/2024; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Female