MAUDE Adverse Event Report: EXACTECH, INC. Novation Acetabular Cup; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 69 yo male, initial right hip implanted on an unknown date, underwent a revision procedure on (b)(6) 2022, for reasons unknown.The surgeon removed the cup and liner and replaced with a competitor¿s devices.The patient was last known to be in stable condition following the event.There are no devices returning as they were sent to pathology.No further information.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis: implanted with a lateralized liner and edge loading/impingement.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified.

• Brand Name: Novation Acetabular Cup
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15971647
• Report Number: 1038671-2022-01595
• Device Sequence Number: 20397821
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 09/30/2026

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 Model Number: NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
• Device Catalogue Number: 136-40-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 03/23/2023; 09/15/2026
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/28/2023; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62MM NOVATION CROWN CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male