MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 136-36-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 04/03/2022

Event Type  Injury  

Manufacturer Narrative

H10.Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: 2497306 164-13-11 - novation element ro s/o col sz 11.4430437 180-65-20 - alteon 6.5mm screw, 20mm.4502445 170-36-00 - biolox delta femoral head 36mm od, +0mm.4578636 101-05-20 - 3.2mm drill bit 20mm 1pk.4594202 186-01-52 - integrip cc, cluster 52mm, g2.

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2016 and then experienced a revision surgical procedure on (b)(6) 2022 approximately 5 years and 5 months after initial implant.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.

• Brand Name: NV GXL LNR, +5LAT, 36MM G2-52/54MM 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: matt collins
• MDR Report Key: 19132221
• MDR Text Key: 340448838
• Report Number: 1038671-2024-00907
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/18/2024

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: 02/18/2019
• Device Catalogue Number: 136-36-52
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 02/20/2014
• 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
• Patient Outcome(s): Required Intervention