MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	132-28-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right hip replacement on (b)(6)2015.Approximately 7 years and 11 months after the initial procedure the patient had a right hip revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023.Post-op diagnosis: 1.Failed left hip total hip replacement arthroplasty.2.Morbid obesity.The surgeon dislocated the hip anteriorly cleared soft tissue around the stem and could see some mild osteolysis that was debrided and did not require bone grafting.The stem was well fixed.The surgeon removed the head and the trunnion was in good condition.I tucked the trunnion along the posterior superior acetabulum and exposed the rim of the acetabulum.There was severe polyethylene wear that beginning to flake some posteriorly, superiorly.A sterile bandage was applied.
Additional Manufacturer Narrative
The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported approximately eight (8) years after an initial right total hip arthroplasty, the patient experienced pain, swelling, joint locking and loss of mobility.As a result, the patient underwent a revision procedure.A revision operative report was provided.Post and preoperative diagnosis noted failed right total hip replacement arthroplasty and morbid obesity.Intraoperatively it was noted the patient had synovitis, osteolysis and joint effusion.No infection evident.Polyethylene wear of the acetabular component was noted posteriorly, superiorly.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5 g2, h6 clinical codes, component code, types of investigation, investigation findings and investigation conclusions.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 LNR, LIPPED, 28MM 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: matt collins ; 3523771140
• MDR Report Key: 17218105
• Report Number: 1038671-2023-01491
• Device Sequence Number: 20377534
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• 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,Followup
• Report Date (Section B): 05/12/2026

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: 07/07/2019
• Device Model Number: 132-28-51
• Device Catalogue Number: 132-28-51
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 02/22/2024; 04/10/2024; 04/22/2026
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 03/14/2024; 04/10/2024; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 221 LB