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

Model Number	136-36-53
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 3536146 101-45-20 - 4.5mm drill bit 20mm.2999671 122-65-20 - 6.5mm acetabular bone screw 20mm.3567377 164-03-10 - element-stem, collared w/ha, std offset, sz 10.2933848 170-36-00 - biolox delta femoral head 36mm od, +0mm.2121952 180-01-58 - nv crown cup clstr hole 58mm group 3.
Event or Problem Description
As reported via legal documentation, this patient had left hip replacement on (b)(6) 2014.He had left hip revision arthroplasty on (b)(6) 2023, approximately 8 years 3 months after their initial procedure, due to slight increasing pain and superior acetabular osteolysis.The surgeon noted that the femoral stem appeared to be quite stable with no movement.The cup was removed with ease, and appeared to have only spot welding.The surgeon also noticed very large cavitary lesion in the supra-acetabular area and extending into the posterior column, but no cortical defect.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.
Additional Manufacturer Narrative
H6.Investigation results - 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 is not confirmed, the devices were not returned.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: michael crader ; 3523782617
• MDR Report Key: 16834655
• Report Number: 1038671-2023-00863
• Device Sequence Number: 2933677
• Product Code: LZO
• 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: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 03/17/2019
• Device Model Number: 136-36-53
• Device Catalogue Number: 136-36-53
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 09/16/2026
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 03/12/2024; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male