MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products.Crown cup,cluster-hole gr.60 (cat# 180-01-60 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the germany competent authorities and as part of the manufacturer's recall campaign, the male patient presented himself for a check-up of the device implanted in 2012 hip prosthesis on the right.The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.In the supplementary ct examination also revealed partial cortical destruction of the inner wall of the pelvis.During the audit surgery on (b)(6) 2023, patient required a socket change to competitor¿s devices.As part of the replacement operation, the curettage and filling of the cyst in the socket using allogeneic spongiosa and the replacement of the prosthetic head.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been due to a combination of the risk factors specified in an hhe and/or from being implanted for over 10 years which led to prosthesis wear and osteolysis.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
After additional review of information and an update to the investigation, the following sections g1, g3, g6, h1, h2, and h6 have been updated accordingly.

• Brand Name: NV GXL LINR, NTRL, 36MM 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18468442
• Report Number: 1038671-2024-00039
• Device Sequence Number: 17940140
• Product Code: JDI
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• 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: 2012
• Device Explanted Year: 2023
• 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): 11/14/2024

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: 12/07/2013
• Device Model Number: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Device Catalogue Number: 130-36-54
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/11/2024; 11/01/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 04/23/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2009
• 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