MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	136-36-53
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a left total hip arthroplasty.Subsequently, nine (9) years later, the patient presented with pain, achiness and loosening.As a result, the patient underwent a left hip revision procedure with a complex reconstruction of the left acetabulum.A revision operative report was provided.Intraoperatively, the patient was noted to have extensive osteolysis.The femoral stem appeared stable.The acetabular cup was mobile.They noted the significant deformity of the acetabulum with fragmenting of the acetabular liner.Due to the patient's supraacetabular defect, it was noted to be difficult to get a good purchase on the new implant with the elected screw, however, upon repositioning the cup and using a bigger screw, the purchase was successful and noted to have a very stable fixation with the bigger screw.The patient was transferred to the recovery room in stable condition.Additionally, it was reported via legal documentation the patient endured joint pain swelling and stiffness, tissue damage, instability, prosthesis wear, and bone graft.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25660688
• Report Number: 1038671-2026-00811
• Device Sequence Number: 5764770
• Product Code: LPH
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 01/27/2014
• Device Catalogue Number: 136-36-53
• 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: 04/27/2023
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 01/29/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male