MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - element stem c'less w/ha std,12/150mm (cat# 164-01-12 / serial# (b)(6).- novation crown cup no-hole.50mm (cat# 180-00-50 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine years post initial left tka, the female patient was revised due to a failed liner.A revision surgery was performed due to liner wear and osteolysis.All components were removed.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information was reported.Sales rep was unable to obtain photo/x-rays.The device is not available for evaluation due to they were disposed at hospital.
Additional Manufacturer Narrative
H3: the revision reported may have been due to a combination of risk factors specified in the hhe, including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: g3, h6 clincial and component codes added.The following sections were corrected: g1 contact name and email.Updated investigation results: the patient/gxl acetabular liner involved was reportedly revised due to prosthesis wear and osteolysis approximately 8.5 years after the index surgery.However, the revised components were not returned to exactech for evaluation and no images or radiographs were provided.The revision reported may have been due to a combination of risk factors specified in hhe including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the reported information and the devices were not available for 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 LINR, NTRL, 28MM ID, GROUP 1 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
• MDR Report Key: 18750135
• Report Number: 1038671-2024-00279
• Device Sequence Number: 6329152
• Product Code: JDI
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: 08/21/2019
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 11/19/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 06/11/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2014
• 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-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female