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

Model Number NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(6) - 132-36-53 - nv gxl lnr, lipped, 36mm id, group 3 cups.(b)(6) - 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6) - 186-01-56 - integrip cc, cluster 56mm, g3.(b)(6) - 188-01-08 - wedge plasma x/o sz 8.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 68 yo male patient, initial right hip implanted on (b)(6), 2017, underwent a revision procedure on (b)(6), 2024, approximately 6 years 2 months post the initial procedure.The surgeon performed a head and liner exchange due to the premature wear of a novation gxl liner.He revised to an xle liner and biolox delta option adapter and head.There were no surgical delays or device breakages during the event.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.No device returns were available as they were sent to legal.No device images were able to be obtained.No further information.

Manufacturer Narrative

Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified, implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified.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 ; 3523164164
• MDR Report Key: 18602639
• MDR Text Key: 334024224
• Report Number: 1038671-2024-00136
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• 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: 04/15/2024

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: 07/02/2018
• Device Model Number: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1729-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 96 KG