MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 136-36-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitant devices: 3639235 164-02-09 - element-stem, collarless w/ha, high offset, sz 9 3874494 101-05-20 - 3.2mm drill bit 20mm 1pk 3887133 180-01-58 - nv crown cup clstr hole 58mm group 3 4008688 180-65-20 - alteon 6.5mm screw, 20mm 4011815 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.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.

Event Description

It was reported that a patient had a right total hip replacement (confirmed on x-ray) procedure on (b)(6) 2015 and then was revised on (b)(6) 2024.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear.The stem was retained and a new head implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.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.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19182466
• MDR Text Key: 341063342
• Report Number: 1038671-2024-00982
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• 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: 04/25/2024

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 Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2014
• 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
• Patient Sex: Male