MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-36-52

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2017, and then experienced revision surgical procedure on (b)(6) 2023 approximately 5 years and 3 months after initial implant.No images were provided.There is no other information available.

Manufacturer Narrative

Concomitants: (b)(6) 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6) 186-03-54 - integrip mh cup sz 54mm.(b)(6) 164-13-08 - novation element ro s/o col sz 8.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.These devices are used in treatment and not in diagnosis.Pending investigation.

• Brand Name: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 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: 18957259
• MDR Text Key: 338307049
• Report Number: 1038671-2024-00638
• Device Sequence Number: 1
• Product Code: LZO
• 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: 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: 06/11/2022
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2023
• Date Device Manufactured: 06/13/2017
• 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-1732-2022
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention