MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-40-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported by legal notification, the patient had an initial right tha on (b)(6) 2017.The patient underwent a revision surgery on (b)(6) 2023 due to premature poly wear and poly recall.The poly and femoral head were exchanged.There was found to be a clean wound with clear synovial joint fluid.There were well-fixed femoral and acetabular components.There was a moderate amount of visible polyethylene wear within the acetabulum from the polyethylene.There was also a moderate amount of osteolysis superior to the acetabulum, as visualized through the screw holes.Putty was used to fill this back side void.A lateralized liner was utilized.The patient was awakened and transferred to recovery in stable condition.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: 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 a combination of the risk factors specified.However, this cannot be confirmed as the devices, radiographs, and images of the explanted devices were not provided.
Event or Problem Description
The patient had a revision surgical procedure, approximately 5 years, 9 months after initial implant.The patient was revised to exactech devices.Procedure: the right hip joint was aspirated of clear synovial joint fluid; this was sent for culture.A complete anterior capsulectomy was then performed.The acetabular component was found to be well fixed to bone.There were no intraoperative complications.There is no other information available.
Additional Manufacturer Narrative
D10.Concomitants: 170-40-00 - biolox delta femoral 40mm od, +0mm, sn (b)(6); 186-01-56 - integrip cc, cluster 56mm,g3, sn (b)(6); 188-01-10 - wedge plasma x/o sz 10, sn (b)(6).These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely a combination of the 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 as the devices, radiographs, and images of the explanted devices were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely a combination of the 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 as the devices, radiographs, and images of the explanted devices 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 LINER LIPPED 40MM ID, GROUP 3 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16697410
• Report Number: 1038671-2023-00605
• Device Sequence Number: 15106589
• Product Code: JDI
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/19/2025
• 2 Devices were Involved in the Event: 1 2

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: 04/14/2018
• Device Catalogue Number: 132-40-53
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 11/20/2023; 02/17/2025; 02/17/2025
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 08/21/2023; 11/20/2023; 02/18/2025; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2013
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male