MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-40-54
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported by the legal department, approximately 4 years post op the initial right tha, this male patient was revised.A bilateral hip x-ray revealed the socket and spacer on the right hip had disintegrated the bone around the screw holding his right hip together.The x-ray of the left hip was fine.
Additional Manufacturer Narrative
D10: concomitants: intergrip acetabular shell multi-hole (186-03-60, sn (b)(6)).Alteon bone screw (180-65-30, sn (b)(6)).Alteon tapered wedge femoral stem (188-01-09, sn (b))6)).Cocr femoral head (142-40-93, sn (b)(6)).H6: investigation results - based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The revision reported was likely the result of a combination of both patient-related conditions and other risk factors.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.
Event or Problem Description
As reported via legal documentation, a patient had right total hip replacement on (b)(6) 2016.They underwent right hip revision surgery on (b)(6) 2022, approximately 6 years 7 months post primary procedure.Revision op report postoperative diagnosis: failed total hip replacement.Massive retroacetabular osteolysis with attachment failure.Also some periprosthetic femoral osteolysis as well, though without destabilizing the femoral implant.The surgeon noted that there was a fair amount of osteolytic membranous infiltration around the margins of the femoral component proximally.Approximately 25-30% of the ingrowth surface appeared to be involved with lysis.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is prosthesis wear and a combination of risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).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 LINER NEUTRAL, 40MM 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15742763
• Report Number: 1038671-2022-01413
• Device Sequence Number: 20296183
• Product Code: JDI
• UDI-Device Identifier: 10885862207104
• UDI-Public: 10885862207104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2018
• Device Catalogue Number: 130-40-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 10/05/2023; 05/02/2025
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 10/13/2023; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 73 YR
• Patient Sex: Male