MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	132-32-55
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.
Event or Problem Description
It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2010, and then experienced revision surgical procedure on (b)(6) 2023 approximately 12 years and 8 months after initial implant.No images were provided.There is no device information provided.There is no other information available.
Additional Manufacturer Narrative
D4: corrected.D10 concomitant devices: (b)(6); 180-01-64 - nv crown cup clstr hole 64mm group 5.(b)(6); 164-02-13 - element-stem, collarless w/ha, high offset, sz 13.(b)(6); 120-65-25 - bone screw 6.5mm dia x 25mm long.(b)(6); 120-65-15 - bone screw 6.5mm dia x 15mm long.(b)(6); 120-65-20 - bone screw 6.5mm dia x 20mm long.(b)(6); 142-32-00 - cocr fem head 32mm +0 offset 12/14.G4: corrected.H4: corrected.H6: corrected.Manufacturer narrative: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failure(s).However, the reported prosthesis wear could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: NOVATION GXL LINER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19068938
• Report Number: 1038671-2024-00761
• Device Sequence Number: 12511139
• Product Code: LZO
• UDI-Device Identifier: 10885862023346
• UDI-Public: 10885862023346
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 108858620233
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2012
• Device Catalogue Number: 132-32-55
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 09/27/2024
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown