MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 130-36-52

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10.Concomitants: (b)(6) 120-65-20 - bone screw 6.5mm dia x 20mm long.(b)(6) 160-01-15 - pf stem tapered plasma ext offset sz 15.(b)(6) 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.(b)(6) 186-01-52 - integrip cc, cluster 52mm, g2.

Event Description

As reported via legal documentation, a patient had right hip replacement surgery on (b)(6) 2016.They subsequently underwent right hip revision surgery on (b)(6) 2023, approximately 7 years 6 months after their primary procedure.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

H10.Additional information.

Event Description

On (b)(6) 2023, revision operative report- polyethylene failure/ extensive synovectomy for metallosis.Findings: significant metallosis, metal acetabular shell and stem well intact, well fixed, polyethylene wear, extensive metallosis.Dressings were applied, patient was extubated, transferred to recovery room in stable condition with an abduction wedge.Devices implanted for approximately 7 years 1 month, before revision.There is no other information available.

Manufacturer Narrative

H10.Updated / additional information - d4 (model #, lot # - na), g1 (fax #), g3, g6, h1, h6 (health effect - clinical code, medical device problem code and component code).H6.Investigation results - 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 is not confirmed, the devices were not returned.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 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: 17279032
• MDR Text Key: 318592666
• Report Number: 1038671-2023-01583
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• 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,Followup,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Model Number: 130-36-52
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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-1732-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male