MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 130-32-51

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

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

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10.Concomitants: 2324143 142-32-00 - cocr fem head 32mm +0 offset 12/14.2448424 164-13-08 - novation element ro s/o col sz 8.3852209 180-01-48 - nv crown cup clstr hole 48mm group.

Event Description

As reported via legal documentation, a patient had left hip replacement surgery on (b)(6) 2015.They underwent left hip revision surgery on (b)(6) 2021, approximately 6 years 6 months post primary procedure.The patient claims to have suffered the following injuries and complications as a result of this exactech device: pain; limited mobility; restrictions in daily activities; blood infection; bone erosion; biopsy; cancer screen; radiology tests; total left hip revision; bone cadaver matrix; additional scarring; increasing problems with pain and difficulty walking post surgical; pharmacology issues with pain impairment; long recovery; stamina.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

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 LINER NEUTRAL, 32MM ID GROUP 1 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: michael crader ; 3523782617
• MDR Report Key: 17375191
• MDR Text Key: 319566528
• Report Number: 1038671-2023-01745
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/21/2018
• Device Model Number: 130-32-51
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2013
• 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-1732-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention