MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial tha, patient had a revision due to polyethylene wear.Patient was revised to a cc inlay vitamin e, lat ø 36, gr.3 cat# 146-36-53 / serial# (b)(6).The device is not available for evaluation.No additional information available.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.Based on the available information, the patient involved meets the following risk criteria for prosthesis wear/osteolysis as specified, implanted with a lateralized liner and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to prosthesis wear is 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 because the device was not available for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
After further review of additional information received the following sections a3.B5, b7, g3, g6 and h2 have been updated accordingly.Section b5: additional information received indicates that due to relatively quickly occurring complaints without trauma in the right implanted in 2016 an artificial hip joint was subjected to a radiological check.One of them was impressive for six years after implantation increased decentration of the head in the inlay with osteolysis of the acetabulum interface as a sign of a clear inlay wear.During an inlay change on (b)(6) 2022, this could be switched to a vitd-cured specially approved inlay can be verified.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: g3 the following sections were corrected: g1 first/last name, email, h6 clinical code, component code, type of investigation, investigation findings, and investigation conclusion.Based on the available information, the patient involved meets the following risk criteria for prosthesis wear/osteolysis as specified: implanted with a lateralized liner, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to prosthesis wear is 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 because the device was not available for evaluation and radiographs were not provided.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, +5 LAT 32MM 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17019490
• Report Number: 1038671-2023-01166
• Device Sequence Number: 17934041
• Product Code: JDI
• UDI-Device Identifier: 10885862024299
• UDI-Public: 10885862024299
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2017
• Device Model Number: NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 136-32-53
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 07/27/2023; 11/13/2024
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 05/31/2023; 08/21/2023; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male