MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-32-52

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

H10.D10.Concomitants: 140-32-93 - 12/14 biolox femoral hd 32mm -3.5, (b)(6).164-03-10 - element-stem, collared w/ha, std offset, sz 10, (b)(6).180-65-25 - alteon 6.5mm screw, 25mm, (b)(6).186-03-52 - integrip mh cup sz 52mm, (b)(6).These devices are used for treatment and not diagnosis.There is no other information available.Pending investigation.

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2016, and then experienced revision surgical procedure on (b)(6) 2023 approximately 6 years and 9 months after initial implant.No images were provided.There is no other information available.

• Brand Name: NV GXL LINR, NTRL, 32MM 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: 18856035
• MDR Text Key: 337104576
• Report Number: 1038671-2024-00427
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022165
• UDI-Public: 10885862022165
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Date Device Manufactured: 01/17/2015
• 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