MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-52
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post op initial right tha, this 75 y/o male patient was revised.The patient presented back to surgeons office with complaints of pain and stiffness in their tha.Upon examination and implant research the patient has a recalled poly implant and early wear with concerns of osteolysis.The patient was scheduled for a revision tha possible poly swap.The patient obtained an acetabular poly liner swap and a femoral head swap with joint debridement.Patient was last known to be in stable condition following the event.Devices are not returning - the implants are sent to the hospital lab and then legal.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6) 180-01-52 - nv crown cup clstr hole 52mm group 2.(b)(6) 164-01-13 - element-stem, collarless w/ha, std offset, sz 13.(b)(6) 170-36-00 - biolox delta femoral head 36mm od, +0mm.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified in the hhe.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
*the following sections have corrected information: (h6) health effect - clinical code, medical device problem code.
Additional Manufacturer Narrative
Based  on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear and osteolysis may have been 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).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.H6: corrected medical device and investigation clinical codes.

• Brand Name: NV GXL LINER LIPPED 36MM ID GROUP 2
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 18083304
• Report Number: 1038671-2023-02697
• Device Sequence Number: 15386079
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 01/24/2025

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: 05/09/2023
• Device Catalogue Number: 132-36-52
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 03/04/2024; 09/19/2024; 01/24/2025
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 03/20/2024; 09/19/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• 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-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 75 YR
• Patient Sex: Male