MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Discomfort (2330); Hip Fracture (2349); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa.It was reported that approximately 85 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.The serial number (b)(6) is confirmed to be a part of recall number: z-1732-2022.
Additional Manufacturer Narrative
Concomitants: "(b)(6) 180-01-52 - nv crown cup clstr hole 52mm group 2.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 188-01-05 - wedge plasma x/o sz 5.The product associated with the reported event is within the scope of recall z-1732-2022.However, there is insufficient information to evaluate whether the subject issue of the recall was a 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: a2; a3; b5.H6: health effect: clinical code, type of investigation.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available liner was used.The most likely underlying cause for the revision reported is prosthesis wear and bone fracture and 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).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.
Event or Problem Description
It was reported that approximately 85 months after a left total hip replacement procedure, the patient underwent a revision procedure to address discomfort and premature wear of the polyethylene liner on imaging.Revision surgery operative notes were provided.Pre-operative and post-operative diagnoses indicated polyethylene wear and osteolysis s/p left total hip arthroplasty with recalled prosthesis, left greater trochanteric fracture, nonunion.Findings indicated no significant wear noted at the trunnion of the well-fixed stem.There was significant wear superolateral within the polyethylene however it remained intact without any areas of full thickness wear.There was an area of lysis particularly at the central and anterosuperior screw holes of the cup.The liner and head were revised to exactech devices.The greater trochanteric fracture was bone grafted.The patient emerged from anesthesia and was extubated in the operating room before being transferred to the pacu in stable condition.No further issues or complications were reported.No additional information is available.

• Brand Name: NV GXL LINER NEUTRAL, 36MM 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20402101
• Report Number: 1038671-2024-03865
• Device Sequence Number: 6546277
• Product Code: JDI
• UDI-Device Identifier: 10885862207081
• UDI-Public: 10885862207081
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 05/21/2022
• Device Catalogue Number: 130-36-52
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female