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

Model Number	NV EHXL ALIP LNR G1 32MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this patient had a tha on (b)(6) 2017.On (b)(6) 2022, the patient underwent a hip revision.The patient left in stable condition.No other known info.
Additional Manufacturer Narrative
Pending evaluation.Biolox delta femoral head, 32mm od, -3.5mm - cn: 170-32-93 / sn: 4413043.
Additional Manufacturer Narrative
H3: the reason for the revison was not reported but is most likely the result of prosthesis wear and/or fracture of the actetabular liner leading to articulation between the femoral head and acetabular cup.The contributions of implant positioning and/or patient related factors to the sequence of events cannot be determined from the reported information; however, the combination of risk factors may have also been a contributing factor to the early prosthesis wear/fracture.
Additional Manufacturer Narrative
H7: z-1732-2022.
Event or Problem Description
Additional information received via legal filing: the patient experienced complications, including but not limited to severe pain, difficulty in walking, metallosis and fractured liner.The patient then underwent a revision surgery on (b)(6) 2022, approximately 4 years, 8 months, after initial implant.It is believed that complications were due to premature polyethylene wear.There is no other patient demographic or medical history available.There is no device return.No additional information is available.
Event or Problem Description
As reported, this patient had a tha.The patient experienced complications, including but not limited to severe pain, difficulty in walking, metallosis, and a fractured liner.The patient then underwent a revision surgery, approximately 4 years, 8 months, after initial implant.There is no other patient demographic or medical history available.There is no device return.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: 2609960 132-32-51 - nv gxl liner lipped 32mm id, group 1 cups.2972181 101-45-30 - 4.5mm drill bit 30mm.4413043 170-32-93 - biolox delta femoral head 32mm od, -3.5mm.4782632 186-01-50 - integrip cc, cluster 50mm, g1.4922785 180-65-30 - alteon 6.5mm screw, 30mm.4931791 188-01-04 - wedge plasma x/o sz 4.4964403 180-65-25 - alteon 6.5mm screw, 25mm." this follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: b1, b2, b5, d1/d2a/d2b, d4, d10, h4, h6: clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion.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 corrected information.The following sections were corrected: h6: investigation findings and investigation conclusions.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 32MM ID, GROUP 1 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 ; 3523771140
• MDR Report Key: 15136916
• Report Number: 1038671-2022-00862
• Device Sequence Number: 12595078
• Product Code: JDI
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 02/18/2018
• Device Model Number: NV EHXL ALIP LNR G1 32MM
• Device Catalogue Number: 132-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 12/15/2022; 04/06/2023; 02/12/2026; 02/17/2026
• Initial Report FDA Received Date: 07/31/2022
• Supplement Report FDA Received Date: 12/13/2022; 12/15/2022; 04/25/2023; 02/16/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown