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

Model Number	NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the germany competent authorities and as part of the manufacturer's recall campaign, the patient presented himself for a check-up of the device implanted in 2016 hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head unusually large osteolysis in the acetabulum as a sign of inlay wear.This could happen to one.Inlay change on (b)(6) 2024 to a vitd-hardened, specially approved inlay (novation xle, neutral liner, group 3, 36 mm i.D., ref 140-36-53, sn (b)(6)).As part of the replacement operation, after the inlay exchange, the determination of the solid cup integrity as well as the curettage and sealing of the cysts.Socket bearing using allogeneic cancellous bone and changing the prosthetic head.
Additional Manufacturer Narrative
Section d10: concomitant products: crown cup,cluster-hole gr.56 (cat# 180-01-56 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the patient/gxl acetabular liner involved was reportedly revised due to early prosthesis wear and osteolysis approximately 7 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 in may have been due to a combination of risk factors 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
After further review of additional information received and the completion of investigation, the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the patient/gxl acetabular liner involved was reportedly revised due to early prosthesis wear and osteolysis approximately 7 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 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.

• Brand Name: NV GXL LNR, NEUTRAL, 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 ; 3525541928
• MDR Report Key: 18733777
• Report Number: 1038671-2024-00255
• Device Sequence Number: 5943486
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: 08/07/2021
• Device Model Number: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-32-53
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 10/11/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/26/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• 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-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male