MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 132-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 07/27/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total hip replacement procedure on (b)(6) 2016 and then was revised on (b)(6) 2023.Patient required revision surgery for issues including but not limited to polyethylene wear.The mostly likely cause for the revision reported due to prothesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

Manufacturer Narrative

D10 concomitant devices: serial number: (b)(6), item number: (b)(4) - full description: element-stem, collarless w/ha, std offset, sz 9.Serial number: (b)(6), item number: 170(b)(4) - full description: biolox delta femoral head 36mm od, -3.5mm.Serial number: (b)(6), item number: (b)(4) - full description: integrip cc, cluster 54mm, g2.H3 the revision reported was likely the result of prosthesis wear of the implant.The cause of prosthesis wear is generally a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19196540
• MDR Text Key: 341242514
• Report Number: 1038671-2024-00996
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207081
• UDI-Public: 10885862207081
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/26/2024

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: 05/09/2021
• Device Catalogue Number: 132-32-52
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2016
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention