MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 5 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 40MM ID, GROUP 5 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Insufficient Information (4580)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6)- 142-40-03 - cocr femoral head 40mm, +3.5 offset 12/14.(b)(6)- 150-07-19 - modular straight stem 15mm x 200mm.(b)(6)- 150-29-03 - modular large meta 29mm.(b)(6)- 158-02-03 - 12/14 lpb m-series neck hi offset +20.(b)(6)- 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6)- 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6)- 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6)- 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6)- 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6)- 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6)-180-65-20 - alteon 6.5mm screw, 20mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 180-65-35 - alteon 6.5mm screw, 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, initial right hip implanted on (b)(6) 2015, underwent a revision procedure due to the poly recall on november 28, 2023, approximately 8 years 9 months post the initial procedure.The head was swapped and liner was revised to a novation exhl lipped liner.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays or device images were available.The explanted devices are not available for return as they were unable to be obtained.No further information.
Event or Problem Description
It was reported via legal documentation approximately 106 months after a right total hip revision procedure, the patient experienced increasing pain and asymmetric wear.The patient underwent a second right hip revision procedure.A revision operative report was provided.Preoperative work up was noted to negative for infection.Post operative diagnosis noted failed right total hip replacement status post revision surgeries, infections.Intraoperatively the surgeon observed significant scar tissue and minimal abductor tissue.Polyethylene was noted to be significantly worn and oxidized, and polyethylene wear debris was observed and cleaned around the acetabulum.The cup was noted to be in excellent position, and it was elected by the surgeon to retain it.There were no surgical or medical interventions reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: b1, b2, h6-clinical codes, medical device problem code and component code.Updated fields: a2, b5, g, g2, g3, g6, h6 investigation codes.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely cause for the reported revision due to prosthesis wear is a combination of the risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.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 LIPPED 40MM ID, GROUP 5 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18352814
• Report Number: 1038671-2023-03023
• Device Sequence Number: 8416070
• Product Code: JDI
• UDI-Device Identifier: 10885862207067
• UDI-Public: 10885862207067
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 05/01/2018
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 5 CUPS
• Device Catalogue Number: 132-40-55
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 05/14/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/20/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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: 60 YR
• Patient Sex: Male