MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six years post initial left tha, the (b)(6) female patient had a revision due g2/36mm neutral gxl liner has early eccentric wear.Surgeon swapped the worn poly for a g2/36mm neutral gxle and a ceramic 36mm head with +3.5 sleeve option.Patient's diagnosis is polyethylene wear and osteolysis.X-rays received.The device will be return.
Additional Manufacturer Narrative
After further review of additional information.Section b5: additional information received indicates that the reason for patient¿s revision was due to early wear and part of the gxl recall.Section d10: concomitant medical products cocr femoral head 40mm, +3.5 offset 12/14 (cat#: 142-40-03 / serial#: (b)(6).Nv crown cup clstr hole 56mm group 3 (cat#: 180-01-56 / serial#: (b)(6).Wedge plasma x/o sz 9 (cat#: 188-01-09 / serial#: (b)(6).Stryker sys 6 sawblade 90x25x1.19mm (11-4118) (cat#: 203-96-46 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt section d6a: implant date.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, 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 revision reported due to early prosthesis wear is a combination of the risk factors including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential could have all contributed to the increased trend in wear/osteolysis related complaints).The most likely cause for the bone fracture could not be determined as adequate information was not provided to conduct a review.However, bone fracture is captured in the product labeling.Section d9: date device returned to manufacturer.

• Brand Name: NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14625444
• Report Number: 1038671-2022-00640
• Device Sequence Number: 17393649
• Product Code: JDI
• UDI-Device Identifier: 10885862207098
• UDI-Public: 10885862207098
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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: 10/23/2019
• Device Model Number: NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-40-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 08/31/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/12/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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-1732-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female