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

Catalog Number 130-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: 1967187 - 120-65-35 - bone screw 6.5mm dia x 35mm long.1934360 - 148-32-93 - 12/14 zirconia head 32mm -3.5mm neck.1610587 - 160-01-13 - pf stem tapered plasma ext offset sz 13 2085783 - 180-01-52 - nv crown cup clstr hole 52mm group 2.H7: z-2117-2021.

Event Description

As reported, the patient had an initial left tha on (b)(6) 2011.The patient complained of pain and was revised on (b)(6) 2024 due to poly wear.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18927410
• MDR Text Key: 337944592
• Report Number: 1038671-2024-00548
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/18/2024

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: 03/27/2015
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2011
• 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: 74 YR
• Patient Sex: Female