MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	132-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, the patient had an initial tha on (b)(6) 2015.The patient was revised on (b)(6) 2021 due to poly wear and massive osteolysis in the acetabulum and proximal femur.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.Correction: d1 and d4 (no device information available; previous device information was incorrect).
Additional Manufacturer Narrative
H3: investigation results - the most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors.The reported loosening may have been the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the acetabular screw.However, this cannot be confirmed because the devices were not returned for evaluation and images or radiographs were not provided.
Additional Manufacturer Narrative
H10.Additional/updated information ¿ a2, b1, b5, b6, d8, g4 510k, h7, h9.D10.No sn or cat#- exactech novation crown cup system 48mm novation crown cup.20mm screw.Size 9 novation element hip stem.32mm cobalt chrome femoral head with 13.5mm neck length.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.H11.Corrected information - d1/d2a/d2b, d4 catalog number/ expiration date/ serial number / unique identifier (udi) #, h4.F6 & f7 should be blank.
Event or Problem Description
Revision operative report of 8 apr 2021- patient was revised to competitor devices- dual mobility shell/ dual mobility liner/metal revision shell and exactech biolox femoral head.Postoperative diagnosis-failed left total hip arthroplasty due to polywear and vertical cup alignment, massive osteolysis in the acetabulum and proximal femur.Procedure: modular femoral head removed.Significant osteolysis in the proximal femur.Novation acetabular component was well fixed, catastrophic wear of the poly liner.Liner was removed, one screw was loose.Significant bone loss in the acetabulum, ilium and pubic osteolysis.Devices were trialed and implanted.Dressings were applied and the patient was transferred to recovery room in stable condition after reversal of anesthesia.Disposition- home with hhc and to have follow up visit 6 weeks post op.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b5, d1, g1, h6: clinical code, component code, type of investigation and investigation findings.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
Revision operative report.Patient was revised to competitor devices- dual mobility shell/dual mobility liner/metal revision shell and exactech biolox femoral head.Postoperative diagnosis-failed left total hip arthroplasty due to polywear and vertical cup alignment, osteolysis in the acetabulum and proximal femur.Procedure: modular femoral head removed.Significant osteolysis in the proximal femur.Novation acetabular component was well fixed, catastrophic wear of the poly liner.Liner was removed, one screw was loose.Significant bone loss in the acetabulum, ilium and pubic osteolysis.Devices were trialed and implanted.Dressings were applied and the patient was transferred to recovery room in stable condition after reversal of anesthesia.Disposition- home with hhc and to have follow up visit 6 weeks post op.There is no other information available.

• Brand Name: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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 ; 3523771140
• MDR Report Key: 15584739
• Report Number: 1038671-2022-01294
• Device Sequence Number: 2690193
• Product Code: LZO
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• 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: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/20/2026
• 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: 12/09/2018
• Device Catalogue Number: 132-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 11/30/2023; 12/18/2023; 02/13/2026
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/04/2023; 12/19/2023; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• 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; SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female