MAUDE Adverse Event Report: EXACTECH INC. NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 132-28-51

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2010 and then experienced a revision surgical procedure on (b)(6) 2022 approximately 12 years after initial implant.There is no device information provided.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.

Manufacturer Narrative

H10: pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: 1584308, 118-01-02 - p-series pf plasma collarless sz 2 12/14.1673440, 142-28-93 - cocr fem head 28mm -3.5 offset 12/14.1791686, 180-01-48 - nv crown cup clstr hole 48mm group 1.

• Brand Name: NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: michael crader
• MDR Report Key: 18958320
• MDR Text Key: 338342047
• Report Number: 1038671-2024-00643
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862023155
• UDI-Public: 10885862023155
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2014
• Device Catalogue Number: 132-28-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Date Device Manufactured: 07/28/2010
• 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