MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number 136-36-53

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 05/29/2018

Event Type  Injury  

Event Description

It is reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2018, with no revision surgery reported.No radiographic images of the device are provided.There is no other information available.

Manufacturer Narrative

Concomitants: 101-05-20 - 3.2mm drill bit 20mm 1pk (b)(6) 170-36-93 - biolox delta femoral head 36mm od, -3.5mm (b)(6) 180-65-20 - alteon 6.5mm screw, 20mm (b)(6) 180-65-20 - alteon 6.5mm screw, 20mm (b)(6) 186-01-56 - integrip cc, cluster 56mm,g3 (b)(6) 190-30-08 - alt ha s clr std sz 8 (b)(6).These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM 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: 19170088
• MDR Text Key: 340898610
• Report Number: 1038671-2024-00958
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• 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: 04/24/2024

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: 03/25/2023
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 03/27/2018
• 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