MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-40-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had an original exactech primary total hip replacement on (b)(6) 2017 by dr.(b)(6).The patient returned to dr.Williams's office having been notified of originally being implanted with a recalled hip poly liner.The patient was booked for revision tha possible femoral head and acetabular poly liner swap on (b)(6) 2023.The patient had a femoral head and poly liner swap.It was noted that the removed recalled liner showed early abnormal eccentric wear.The patient left the or stable.During this case the femoral head impactor tip had a piece that broke off of it when using the instrument to disengage the femoral head from the neck taper.Pictures of the broken instrument are attached.It will be returned and a new one ordered to replace it.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 4881184 186-01-60 - integrip cc, cluster 60mm, g4.4884382 170-40-00 - biolox delta femoral 40mm od, +0mm.4917680 190-20-11 - alt ha s noclr std sz 11.
Additional Manufacturer Narrative
H3: 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
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 health effect, component, and investigation clinical codes.

• Brand Name: NV GXL LINER LIPPED 40MM ID, GROUP 4 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18140311
• Report Number: 1038671-2023-02781
• Device Sequence Number: 18138085
• Product Code: JDI
• UDI-Device Identifier: 10885862207050
• UDI-Public: 10885862207050
• 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: 2017
• 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
• Report Date (Section B): 12/11/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2021
• Device Catalogue Number: 132-40-54
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 03/04/2024; 12/11/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/21/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2016
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 140 KG