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

Catalog Number	132-32-51
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tha on (b)(6) 2019.The patient presented back to the surgeon's office with complaints of pain in the right hip.The patient was implanted with a novation gxl hip liner that is now recalled.The patient underwent a total hip revision on (b)(6) 2023.The exactech femoral head, exactech novation crown cup and the liner were removed from the patient.The patient was re-implanted with a competitor product to their acetabulum and an exactech biolox delta option head and sleeve.The patient was last known to be in stable condition following the event.There was no reported breakage of a device, and a 15-30 minute surgical delay/prolongation.The patient did not experience any adverse events as a result of the surgical delay/prolongation.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(4) 164-11-11 - novation element ro s/o sz 11.(b)(4) 170-32-03 - biolox delta femoral head 32mm od, +3.5mm.(b)(4) 180-01-50 - nv crown cup clstr hole 50mm group 1.H7: z-2133-2021.
Additional Manufacturer Narrative
H10.Additional information -h6, clinical code.H6.Investigation results - the nv gxl liner lipped 32mm id, group 1 cups, serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision reported in (b)(4) is a combination of risk factors specified in hhe-2020-09-11-02.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.H6: corrected medical device, component, and investigation clinical codes.

• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17393967
• Report Number: 1038671-2023-01770
• Device Sequence Number: 6054018
• Product Code: JDI
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: 05/05/2021
• Device Catalogue Number: 132-32-51
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 01/08/2024; 11/23/2024
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 01/08/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female