MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 132-36-54

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2012

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2012, with no reported revision.No other patient information / medical history reported.No radiographic images of the device are provided.The device will not be returned.There is no other information available.

Manufacturer Narrative

D10.H10.Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: 120-65-25 - bone screw 6.5mm dia x 25mm long (b)(6).160-01-16 - pf stem tapered plasma ext offset sz 16 (b)(6).170-36-00 - biolox delta femoral head 36mm od, +0mm (b)(6).180-01-60 - nv crown cup clstr hole 60mm group 4 (b)(6).620-00-02 - platelet rich plasma kit with spray tips (b)(6).620-11-02 - accelerate conc.Sys rep by 620-12-02 (b)(6).

• Brand Name: NV GXL LNR, LIPPED, 36MM ID GROUP 4 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: 19132045
• MDR Text Key: 340448235
• Report Number: 1038671-2024-00903
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862023438
• UDI-Public: 10885862023438
• Combination Product (y/n): N
• 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: 12/04/2016
• Device Catalogue Number: 132-36-54
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 12/06/2011
• 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
• Patient Outcome(s): Required Intervention