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

Catalog Number 130-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): cup.

Event Description

It was reported that this 73 y/o male patient's right hip was revised due to the poly wear.Patient had cup and liner removed and a smith and nephew ceramic cup and liner were implanted.Patient was last known to be in stable condition following the event.Device will not be returning, hospital threw it away.

Manufacturer Narrative

Section h10: (d1) brand name: nv gxl linr, ntrl, 32mm id, group 2 cups (d4) catalog number: 130-32-52, serial number: (b)(6) expiration date: 10-feb-2020, unique identifier (udi) #: (b)(4).(g5) pma/510(k)number: k070479 (h3) the revision reported was likely the result of eccentric prosthesis wear of the acetabular liner over 7 years of implantation.However, this cannot be confirmed as the devices are not available for evaluation.(h4) device manufacture date: 13-feb-2015 section h11: *the following sections have corrected information: (d10) concomitant device(s): 186-01-54, 3718125 - integrip cc, cluster 54mm, g2 (h6) component code: 734, bearings.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15069801
• MDR Text Key: 296288883
• Report Number: 1038671-2022-00824
• Device Sequence Number: 1
• Product Code: MEH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2020
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male