MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LIPPED LINER FOR 32MM ID; SEE H10

Model Number	12/14 ZIRCONIA HEAD 32MM -3.5MM NECK
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.Concomitants: 1661585 164-03-12 - element-stem, collared w/ha, std offset, sz 12.1618079 180-01-52 - nv crown cup clstr hole 52mm group 2.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 72 yo male patient, initial right hip implanted on (b)(6) 2010, underwent a revision procedure on (b)(6) 2023, approximately 12 years 11 months post the initial procedure.The patient returned to the dr.¿s office complaining about pain and dissatisfaction of their right primary hip.Upon examination and imaging, the poly showed to be worn and had lysis behind the implant.The head and poly liner were swapped.Bone substitute was placed behind the cup implant to fill bone voids and a new vitamin e-lipped liner and a 36mm head were re-implanted.There were no surgical delays reported.The patient was last known to be in stable condition following the event.No devices available for return.The implants are sent to the lab and legal and are not given to the representative.No further information.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of polyethylene wear of the acetabular component and osteolysis after being implanted for almost 13 years.However, this cannot be confirmed as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4, g4, h6 - health effect - clinical code, type of investigation, investigation conclusion and h11 a definitive root cause was unable to be determined; however, may have resulted from polyethylene wear of the acetabular component and osteolysis after being implanted for almost 13 years.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NOVATION GXL LIPPED LINER FOR 32MM ID
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16588298
• Report Number: 1038671-2023-00481
• Device Sequence Number: 20307181
• Product Code: LPH
• UDI-Device Identifier: 10885862027887
• UDI-Public: 10885862027887
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 08/10/2014
• Device Model Number: 12/14 ZIRCONIA HEAD 32MM -3.5MM NECK
• Device Catalogue Number: 148-32-93
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 04/09/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 08/09/2023; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2009
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 109 KG