MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 130-36-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2021

Event Type  Injury  

Event Description

As reported via legal documentation, a patient had left hip replacement on (b)(6) 2012.They subsequently had left hip revision surgery on (b)(6) 2022, approximately 9 years 6 months after their primary surgery.On (b)(6) 2022, op report noted to have found eccentric polyethylene wear with previously documented acetabular wall defect with intact columns, both anterior, posterior and anterior, low anterior inferior wall defect.The patient was taken to recovery room.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

Pending investigation.D10.Concomitants: (b)(6) 164-02-12 - element-stem, collarless w/ha, high offset, sz 12.(b)(6) 130-36-53 - nv gxl linr, ntrl, 36mm id, group 3 cups.(b)(6) 180-00-56 - nv crown cup no hole 56mm group 3.(b)(6) 148-36-00 - 12/14 zirconia head 36mm rep by 170-36-00.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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 ; 3523782617
• MDR Report Key: 17268890
• MDR Text Key: 318580510
• Report Number: 1038671-2023-01568
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• 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
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/08/2016
• Device Model Number: 130-36-53
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2011
• 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: 73 YR
• Patient Sex: Male