MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 130-36-54

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10.Concomitants: 170-36-03 - biolox delta femoral head 36mm od, +3.5mm; (b)(6), 180-01-60 - nv crown cup clstr hole 60mm group 4; (b)(6), 180-65-25 - alteon 6.5mm screw, 25mm; (b)(6), 180-65-25 - alteon 6.5mm screw, 25mm; (b)(6), 180-65-25 - alteon 6.5mm screw, 25mm; (b)(6), 188-01-11 - wedge plasma x/o sz 11; (b)(6).

Event Description

As reported via legal documentation, a patient had right hip replacement on (b)(6) 2016.They underwent right hip revision surgery on (b)(6) 2023, approximately 6 years 5 months after their primary procedure.On (b)(6) 2023 op report noted there was visible evidence of adverse local tissue reaction.The stem was well fixed.There was some mild osteolysis that did not require bone grafting.There was some heterotopic bone anteromedially that was removed.The trunnion was in good condition.There was cracking at the rim of the acetabulum with significant polyethylene wear.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: matt collins ; 3523782617
• MDR Report Key: 17317492
• MDR Text Key: 319092595
• Report Number: 1038671-2023-01644
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Model Number: 130-36-54
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male