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

Model Number NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: ziramic zirconia femoral head 32mm o.D., -3.5mm 12/14 (cat# 148-31-93 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, the 40 y/o female patient bilateral hip arthroplasty done approximately ten years ago.The patient had significant poly wear, resulting in bilateral hip revision.Patient's poly and head were swap.Patient was revised to exactech implants, novation xle neutral liner, group 2, 32mm, biolox option adaptor, +0mm, 12/14 and biolox option femoral head, 32mm o.D.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

The revision reported may be the result of prosthesis wear.The prosthesis wear may have been due to a combination of risk factors specified in the hhe and being implanted for more than 10 years.The patient involved in this case meets the following risk criteria for early wear as specified in the hhe: significant edge loading of the femoral head on the acetabular liner.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18466095
• MDR Text Key: 332386815
• Report Number: 1038671-2024-00033
• Device Sequence Number: 1
• Product Code: JDI
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2018
• Device Model Number: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2013
• 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
• Treatment: 12/14 ZIRCONIA HEAD 32MM -3.5MM NECK; BONE SCREW 6.5MM DIA X 30MM; INTEGRIP CC, CLUSTER 52MM, G2; NOVATION ELEMENT RO S/O SZ 12
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female