MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 4 CUP; SEE H10

Model Number	138-36-54
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190); Lack of Effect (4065)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.D10.Concomitants: 3735827, 186-01-60 - integrip cc, cluster 60mm, 3743462, 180-65-20 - alteon 6.5mm screw, 20mm, 4090664, 180-65-25 - alteon 6.5mm screw, 25mm.H6.Investigation results - the nv gxl lnr device with serial number: (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.No other information is available.
Event or Problem Description
It was reported via legal documentation that a patient had a total left hip arthroplasty on (b)(6) 2015 and then approximately 6 years later, on (b)(6) 2021 the patient experienced a revision surgery.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
It was reported via legal documentation that a patient had a total left hip arthroplasty, subsequently, six (6) years later, the patient underwent a revision procedure due to prosthesis wear.There was no other patient demographic or medical history provided.No information on the surgical procedure was provided.Additionally, it was reported via legal documentation that the patient suffered joint pain, swelling, stiffness, limited range of motion, loss of mobility.No additional information is available.

• Brand Name: NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 4 CUP
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17038532
• Report Number: 1038671-2023-01196
• Device Sequence Number: 12391106
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 06/17/2019
• Device Model Number: 138-36-54
• Device Catalogue Number: 138-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown