MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
Medical Device Problem Codes	Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the female patient had a revision of left hip due to loosening.Gxl head swapped, competitor's replaced cup side.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos and x-rays received.The device is not available for evaluation.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of an insufficient bond between the acetabular cup and the acetabular bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Event or Problem Description
It was reported that the patient underwent an initial left total hip arthroplasty.Subsequently, it was reported that the patient experienced loosening.As a result, the patient underwent a left hip revision an unknown amount of time after initial implantation.No further patient impact reported.No further information available.

• Brand Name: UNKNOWN ACETABULAR CUP
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16418096
• Report Number: 1038671-2023-00200
• Device Sequence Number: 3364435
• Product Code: JDI
• 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 Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/30/2026

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 Model Number: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/15/2024; 06/30/2026
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/23/2024; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Female