MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-28-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Scar Tissue (2060); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 2054905 120-65-35 - bone screw 6.5mm dia x 35mm long 2134091 142-28-07 - cocr fem head 28mm +7 offset 12/14 2313339 118-41-01 - p-series pf plasma h/o collarless sz 1 12/14 2454270 101-05-01 - drill bit 1 pk 3.2mm dia x 32mm lng 2491586 180-01-52 - nv crown cup clstr hole 52mm group 2 2606123 120-65-15 - bone screw 6.5mm dia x 15mm long 2684492 120-65-15 - bone screw 6.5mm dia x 15mm long.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 130 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, worsening osteolysis, and cyst superior to acetabular component.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.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 a combination of 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) and being implanted for more than 10 years.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 LNR, NEUTRAL, 28MM ID, GROUP 2 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: 19370631
• Report Number: 1038671-2024-01394
• Device Sequence Number: 7678145
• Product Code: JDI
• UDI-Device Identifier: 10885862022073
• UDI-Public: 10885862022073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 02/04/2025

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: 02/25/2017
• Device Catalogue Number: 130-28-52
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2012
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown