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 07/16/2013

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2013, 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: 2428069 164-13-11 - novation element ro s/o col sz 11, 2488332 170-36-00 - biolox delta femoral head 36mm od, +0mm, 2642576 180-01-54 - nv crown cup clstr hole 54mm group 2.

• 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: 19132201
• MDR Text Key: 340445652
• Report Number: 1038671-2024-00906
• 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: 05/01/2018
• 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: 05/02/2013
• 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