MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: cocr fem head 32mm -3.5 offset 12/14 (cat# 142-32-93 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 13 years post initial left tha, the 62 y/o male patient had a revision due to poly recall.Patient had the liner removed as well as cocr head.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due the implants were kept by the hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear after being implanted for approximately 13 years.Additional contributing factors to the reported failure may have been the result of a combination of the 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 confirmed as the device was not available for evaluation, and radiographs were not provided at the time of this evaluation.
Additional Manufacturer Narrative
H6: corrected health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear after being implanted for approximately 13 years.Additional contributing factors to the reported failure may have been the result of 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).However, this cannot be confirmed as the device was not available for evaluation, and radiographs were not provided at the time of this evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D4: model number.D10 concomitant devices: (b)(6) 142-32-93 - cocr fem head 32mm -3.5 offset 12/14.(b)(6) 160-01-15 - pf stem tapered plasma ext offset sz 15.(b)(6) 180-03-56 - nv cwn cup mlt hl rf, 56mm group 2.(b)(6) sc45-30 - bone screw 4.5mm dia x 30mm lng.(b)(6) sc45-50 - bone screw 4.5mm dia x 50mm lng.(b)(6) sc45-50 - bone screw 4.5mm dia x 50mm lng.The revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear after being implanted for approximately 13 years.Additional contributing factors to the reported failure may have been the result of 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).However, this cannot be confirmed as the device was not available for evaluation, and radiographs were not provided at the time of this evaluation.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 32MM ID GROUP 2 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 18919049
• Report Number: 1038671-2024-00529
• Device Sequence Number: 17865643
• Product Code: JDI
• UDI-Device Identifier: 10885862023315
• UDI-Public: 10885862023315
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2013
• Device Model Number: N/A
• Device Catalogue Number: 132-32-52
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 10/18/2024; 10/18/2024
• Initial Report FDA Received Date: 03/16/2024
• Supplement Report FDA Received Date: 05/15/2024; 10/21/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• 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: BONE SCREW 4.5MM DIA X 30MM LNG; BONE SCREW 4.5MM DIA X 50MM LNG (X2); NV CWN CUP MLT HL RF, 56MM GROUP 2; PF STEM TAPERED PLASMA EXT OFFSET SZ 15; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male