MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	138-36-52
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had initial left hip replacement surgery on (b)(6)2011.They subsequently underwent left hip revision surgery on (b)(6 2021, approximately 9 years 10 months post primary procedure.The patient claims to have suffered the following injuries/complications: joint pain, joint swelling and stiffness, tissue damage, revision surgery, polyethylene wear, osteolysis, revision with bone graft.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.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H10.D10.Concomitants - product information: 3976742 188-01-03 - wedge plasma x/o sz 3; 4060945 180-65-20 - alteon 6.5mm screw, 20mm; 4154646 170-28-00 - biolox delta femoral head 28mm od, +0mm; 4430397 180-65-20 - alteon 6.5mm screw, 20mm; 4635261 186-01-50 - integrip cc, cluster 50mm.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
Revision operative report: postoperative diagnosis(es): failed left total hip arthroplasty.Revision of femoral and acetabular components.She was seen and evaluated and being followed for a period of time for accelerated polywear, patient presented with pain.Large uncontained cystic defect at the posterior aspect of the femur and at the medial aspect.This was debrided and appeared to be membrane consistent with osteolysis.Large cystic osteolytic lesions circumferential to the femur.Significant wear and discoloration of the plastic with gross failure at the posterior aspect where the lip was posteriorly.Patient tolerated the procedure well, was transported to recovery room in stable condition.There is no additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h6 - health effect - clinical code, component code, type of investigation, investigation findings, h7 and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.The patient involved meets the following risk criteria for early prosthesis wear: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a lateralized liner.A definitive root cause was unable to be determined; however, may have resulted from a combination of 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).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, 10 DEG FACE, 36MM ID, GRP 2 CUP
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17398233
• Report Number: 1038671-2023-01782
• Device Sequence Number: 20313816
• Product Code: LZO
• UDI-Device Identifier: 10885862024886
• UDI-Public: 10885862024886
• 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: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2026

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: 05/04/2015
• Device Catalogue Number: 138-36-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: Not provided; 06/05/2024; 04/20/2026
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 04/30/2024; 06/05/2024; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2011
• 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.; UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female