MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5083867 101-05-30 - 3.2mm drill bit30mm 1pk.4300556 164-12-12 - novation element ro x/o sz 12.4911940 170-40-03 - biolox delta femoral head 40mm 0d, +3.5mm.4559372 180-65-40 - alteon 6.5mm screw, 40mm.5112913 186-01-58 - integrip cc, cluster 58mm, g3.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 73 yo female patient, initial right hip implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2024, approximately 6 years 1 month post the initial procedure.The patient returned to the surgeon with a recalled hip liner and was scheduled for a revision.The acetabular poly liner and the femoral head were replaced to a biolox delta adapter 16/18-12/14; +3.5mm sn: (b)(6), biolox delta option femoral head 40mm od sn: (b)(6), and a nv ehxl lipped lnr g3 40mm sn: (b)(6).There were no surgical delays or device breakages during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.They were sent to the hospital¿s lab and legal dept.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1, g3, h6.The following sections were corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, g.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the reported revision due to prosthesis wear is a combination of the risk factors specified in 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.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 3 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 ; 3523782617
• MDR Report Key: 18813258
• Report Number: 1038671-2024-00364
• Device Sequence Number: 8308264
• Product Code: JDI
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-40-53
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 75 KG