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

Model Number NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 4884389 - 170-40-00 - biolox delta femoral 40mm od, +0mm 4670920 - 186-01-56 - integrip cc, cluster 56mm,g3 4908584 - 188-01-11 - wedge plasma x/o sz 11 additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 72 yo male patient, initial right hip implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2024, approximately 6 years 6 months post the initial procedure.The patient was revised due to premature wear of their gxl liner.The surgeon did a head and liner exchange.There were no device breakages or surgical delays during the procedure.The patient was last known to be stable following the event.No x-rays or device images were available.The explanted devices are not able to be returned.They were sent to legal.No further information.

Manufacturer Narrative

H3: the patient/gxl acetabular liner involved was reportedly revised due to prosthesis wear approximately 6 years and 7 months after the index surgery.However, the revised components were not returned to exactech for evaluation and no images or radiographs were provided.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified in the hhe.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.

• Brand Name: NOVATION
• Type of Device: 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18850283
• MDR Text Key: 337041028
• Report Number: 1038671-2024-00411
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-40-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 04/14/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1732-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 52 KG