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

Catalog Number	180-00-56
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had left hip replacement, they subsequently had left hip revision surgery approximately 9 years 6 months after their primary surgery.Op report - postop diagnosis: 1.Aseptic loosening of left press-fit hip.2.Osteolysis of acetabulum, posterior wall, anterior wall.Findings: eccentric polyethylene wear with previously documented acetabular wall defect with intact columns, both anterior, posterior and anterior, low anterior inferior wall defect.Patient was having increasing pain.Synovitis was debrided.The patient was taken to recovery room.Patient was revised to competitor's devices.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H10.Related: mfr #1038671-2023-01568 report 1 of 2.H11.Additional manufacturer narrative- report 2 of 2.D10.Concomitants: (b)(6) , 164-02-12 - element-stem, collarless w/ha, high offset, sz 12; (b)(6) , 130-36-53 - nv gxl linr, ntrl, 36mm id, group 3 cups; (b)(6) , 180-00-56 - nv crown cup no hole 56mm group 3; (b)(6) , 148-36-00 - 12/14 zirconia head 36mm.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Additional Manufacturer Narrative
B1- updated.B2- updated.D6b- updated to 26oct2021.H6: corrected health effect - clinical code, health effect - impact code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.The reason for the revision reported in incident cannot be confirmed from the information provided but may be the result of prosthesis wear and acetabular loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: NOVATION
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19833428
• Report Number: 1038671-2024-02547
• Device Sequence Number: 12606119
• Product Code: JDI
• UDI-Device Identifier: 10885862036889
• UDI-Public: 10885862036889
• Combination Product (Y/N): N
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 11/11/2024

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: 05/09/2016
• Device Catalogue Number: 180-00-56
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male