MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 132-32-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/04/2009

Event Type  Injury  

Event Description

As reported via legal documentation, a patient had left hip replacement on (b)(6)2009.On or around (b)(6)2023, radiology studies demonstrated polyethylene wear, bone loss and osteolysis, in the setting of recalled implants, leading to the recommendation for explantation, which is tentatively planned for the fall of 2023.The patient has additionally suffered bilateral hip osteolysis and bone loss and will, upon information and belief, require bilateral hip prostheses explantation in the near future.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

Pending investigation.

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 LNR, LIPPED, 32MM ID, GROUP 3 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: geoff gannon ; 3523782617
• MDR Report Key: 17401515
• MDR Text Key: 319923419
• Report Number: 1038671-2023-01789
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862023322
• UDI-Public: 10885862023322
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Catalogue Number: 132-32-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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
• Patient Outcome(s): Required Intervention