MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
Medical Device Problem Codes	Flaked (1246); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tha on (b)(6) 2017.The patient was revised on (b)(6) 2022 due to pain.The surgeon replaced the gxl to xle and adaptor biolox with head.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 170-32-93 - biolox delta femoral head 32mm od, -3.5mm sn: (b)(4), 186-01-48 - integrip cc, cluster 48mm, g1 sn: (b)(4), 188-00-05 - wedge plasma s/o sz 5 sn: (b)(4).
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient's condition.H7: z-1732-2022.
Additional Manufacturer Narrative
Additional information: b4.Correction: h6 clinical code, problem code, and component code.
Event or Problem Description
There was found to be a clean wound with clear synovial joint fluid.There was a well-fixed femoral stem and acetabular shell.There was visible polyethylene wear of the acetabular polyethylene as well as visualized polyethylene debris.A lateral liner was utilized.Retractors were then placed around the femoral neck capsule and aspiration of the capsule yielded clear synovial joint fluid.This was sent for culture.An anterior capsulectomy was then performed.Part of this capsular tissue was also sent for culture.Scar tissue around femoral trunnion was debrided then the hip dislocated, and the ceramic head was dis impacted from the femoral stem.There was found to be visualized polyethylene wear within the apex of the acetabular poly.The poly component was removed using the screw technique.The acetabular metal shell component was found to be well fixed to bone and the femoral stem was found to be well fixed to the femur.Trial reduction was performed with a lateralized liner and a -3.5 trial head.The hip was reduced and found to have good leg lengths at the medial malleoli, excellent stability, full extension, and external rotation, as well as flexion at 90 degrees and internal rotation.Trials were removed, finals placed and found to have good leg lengths and excellent stability.The patient was awakened and transferred to recovery in stable condition.There were no complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a, h4, h6.Mdr section codes updated/corrected: a, b, c, d.The most likely cause for the revision reported due to early 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).The prosthesis wear reported could not be confirmed from the image and radiograph 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 32MM ID, GROUP 1 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 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15349089
• Report Number: 1038671-2022-01025
• Device Sequence Number: 12043389
• Product Code: JDI
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2021
• Device Model Number: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Device Catalogue Number: 132-32-51
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 09/24/2024; 08/29/2025
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/13/2022; 10/11/2024; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female