MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number 132-36-53

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 09/28/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2015, and then experienced revision surgical procedure on (b)(6) 2023 approximately 7 years and 9 months after initial implant.Op report ; postoperative diagnosis; poly wear.No images were provided.There is no other information available.

Manufacturer Narrative

Concomitants: 4100237 01-010-16-4195 - mono rev stem std 16x195 4165710 170-36-03 - biolox delta femoral head 36mm od, +3.5mm 4126341 180-65-30 - alteon 6.5mm screw, 30mm 4125412 186-01-58 - integrip cc, cluster 58mm, g3 these devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• 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: 19105077
• MDR Text Key: 340149757
• Report Number: 1038671-2024-00838
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• 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: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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: 11/30/2016
• Device Catalogue Number: 132-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 04/15/2024
• Date Device Manufactured: 12/03/2011
• 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 Age: 58 YR
• Patient Sex: Male