MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV CROWN CUP CLSTR HOLE 56MM GROUP 3

Model Number	180-01-56
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: 56mm novation crown cup.No information has been provided: (serial number, and exp date).
Event or Problem Description
As reported, this (b)(6) y/o female¿s present with right hip pain and was scheduled for a revision due to osteolysis.The patient was last known to be in stable condition following the event.Device not returned due to hospital policy.This patient is known to have arthritis.
Additional Manufacturer Narrative
The evaluation noted that based upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.This cause of the reported event is most likely the osteolysis and patient conditions.Concomitant devices: 56mm novation crown cup.
Event or Problem Description
Additional information reported via a legal notification that a male patient, initial right hip implanted on (b)(6), 2014, underwent a revision procedure on (b)(6), 2020, approximately 5 years 10 months post the initial implant procedure due to acetabular loosening, poly wear and osteolysis.The surgeon indicated that the femoral component was "very well fixed with no loosening whatsoever," but that "the cup was completely loosened.¿ the surgeon inspected the acetabular and found a large but contained defect centrally, involving the medial wall likely due to poly wear and osteolysis.The acetabular components and the femoral heads were revised.The patient continues to endure painful recovery and rehabilitation process from his revision.
Additional Manufacturer Narrative
D10: concomitants: 2568595 130-36-53 - nv gxl linr, ntrl, 36mm id, group 3 cups - recall device.2927690 120-65-30 - bone screw 6.5mm dia x 30mm long.Additional information, including the product investigation, will be submitted within 30 days of receipt.B5: female stated in initial report corrected to male.D10: concomitant devices: - 56mm novation crown cup stated in the initial report is incorrect.See additional mfg narrative for correct concomittants.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of acetabular side loosening secondary to osteolysis.However, the potential contributions of particle-induced osteolysis from prosthesis wear, acetabular positioning, off-label use of multiple manufacturers¿ components, and prior surgical history to the sequence of events cannot be determined as the explanted devices and radiographs were not available for evaluation and limited clinical information was available at the time of evaluation.

• Brand Name: NOVATION
• Common Device Name: NV CROWN CUP CLSTR HOLE 56MM GROUP 3
• 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: kate jacobson ; 3523782617
• MDR Report Key: 9866320
• Report Number: 1038671-2020-00257
• Device Sequence Number: 2951856
• Product Code: JDI
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• Combination Product (Y/N): N
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2023

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 Expiration Date: 02/03/2019
• Device Model Number: 180-01-56
• Device Catalogue Number: 180-01-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 12/22/2022; 07/19/2023
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 10/14/2020; 01/17/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2118-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male