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

Model Number	NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884); Joint Dislocation (2374)
Date of Event	07/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 4189224- 170-28-00 - biolox delta femoral head 28mm od, +0mm.4249065- 180-65-20 - alteon 6.5mm screw, 20mm.4323739- 180-65-20 - alteon 6.5mm screw, 20mm.4186698- 186-01-48 - integrip cc, cluster 48mm, g1.4294821- 188-00-08 - wedge plasma s/o sz 8.Pending investigation.
Event or Problem Description
As reported via legal documentation the female patient had a left hip replacement on (b)(6) 2016.Approximately 6 weeks after the initial procedure the patient had a left hip revision on (b)(6) 2016.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.Revision op report on (b)(6) 2016.Diagnosis: local dislocation of left total hip the fascia was entered and a hematoma was noted.This appeared to be benign.This was cultured.It was thoroughly evacuated.There has been a total left hip arthroplasty.There is complete dislocation of the femoral head from the acetabular cup.The femoral head is displaced superiorly.There is no bone fracture or destructive bone lesion.
Additional Manufacturer Narrative
H10.Additional/updated information ¿ b5, g2, h6 health effect - clinical code & medical device problem code, h7, h8, & h9.H3.Investigation results- the cause of the patient¿s hip dislocation events and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, fainting/fall, unique anatomy, or other condition that impacts the performance of the device.The patient had a traumatic event which could impact the devices.Dislocation and revision are noted in the ifu.These devices are used for treatment not diagnosis.
Event or Problem Description
Additional information -approximately 6 weeks out following a left primary hip replacement who was doing well until she fainted and passed out at home and dislocated her hip.This was reduced in the er, however, 5 days later she was getting up from a seated position and felt it dislocate again and was reduced in the er that night.It dislocated a third time /patient was seen for revision.At the time of the closed reduction, she was unstable in flexion and internal rotation.There is no operative disposition noted in the operative report.There is no mention of device malfunction or wear in the operative report.There is no additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4, g4, h4, h6 - health effect - clinical code, medical device problem code, component code, type of investigation and h11.The cause of the patient¿s hip dislocation events and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, fainting/fall, unique anatomy, or other condition that impacts the performance of the device.The patient had a traumatic event which could impact the devices.Dislocation and revision are noted in the ifu.These devices are used for treatment not diagnosis.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NOVATION HIP 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17377779
• Report Number: 1038671-2023-01746
• Device Sequence Number: 7261602
• Product Code: JDI
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 02/11/2019
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• 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: 06/25/2023
• Supplement Date Received by Manufacturer: 05/14/2024; 04/07/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 05/14/2024; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2014
• 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-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown