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

Catalog Number	130-36-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 188-01-12 - wedge plasma x/o sz 12.(b)(6), 180-01-60 - nv crown cup clstr hole 60mm group 4.(b)(6), 188-01-12 - wedge plasma x/o sz 12.(b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6), 180-01-60 - nv crown cup clstr hole 60mm group 4.(b)(6), 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6), 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6), 101-05-30 - 3.2mm drill bit30mm 1pk.The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was the cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 104 months after a right total hip replacement procedure, the patient has experienced prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The most likely cause for the reported revision due to prosthesis wear and osteolysis is a combination of the risk factors specified such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).Additionally, the sequence of events as related to the reported wear cannot be confirmed and the contributions of this to the reported event cannot be determined.However, this cannot be confirmed as the devices were not returned for evaluation, and images 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 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19390530
• Report Number: 1038671-2024-01464
• Device Sequence Number: 7049358
• Product Code: JDI
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 05/02/2018
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Male