MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-40-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Failure of Implant (1924); Scar Tissue (2060); Osteolysis (2377); Joint effusion (4849)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 180-65-40 - alteon 6.5mm screw, 40mm.(b)(6) 170-40-00 - biolox delta femoral 40mm od, +0mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left hip revision on (b)(6) 2018.Approximately 4 years and 11 months after the first revision the patient had a second left hip revision on (b)(6) 2023.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) 2023.Diagnosis: failed left total hip replacement.The patient had extensive scarring.The patient encountered a huge adverse local tissue reaction and a large fluid collection and a dark gray trochanteric bursitis that had to be debrided.There was an opening breaking through to his greater trochanter that the surgeon thought contributed to trochanter was fractured.This had to all be curettaged and bone grafted.The acetabular component also had osteolysis that had required extensive curratage and bone grafting.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of the osteolysis and bone fracture.Osteolysis of the recalled gxl polyethylene was also identified in the revision operative notes.The osteolysis may have been the result of a combination of the risk factors specified in the hhe.However, the osteolysis and bone fracture cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.Correction: h6 clinical code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, associated reports: 1038671-2024-03816, 1038671-2024-04994.The most likely underlying cause for the revision reported is a combination of risk factors specified such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) acetabular loosening, and bone fracture.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS
• 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18482904
• Report Number: 1038671-2024-00064
• Device Sequence Number: 11468285
• Product Code: JDI
• UDI-Device Identifier: 10885862207104
• UDI-Public: 10885862207104
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 12/23/2024

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: 04/26/2021
• Device Catalogue Number: 130-40-54
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 08/01/2024; 12/19/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 08/09/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male