MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 138-36-52

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

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

Event Date 08/18/2021

Event Type  Injury  

Event Description

As reported via legal documentation, a patient had initial left hip replacement surgery on (b)(6)2011.They subsequently underwent left hip revision surgery on (b)(6 2021, approximately 9 years 10 months post primary procedure.The patient claims to have suffered the following injuries/complications: joint pain, joint swelling and stiffness, tissue damage, revision surgery, polyethylene wear, osteolysis, revision with bone graft.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

H10.D10.Concomitants - product information: 3976742 188-01-03 - wedge plasma x/o sz 3; 4060945 180-65-20 - alteon 6.5mm screw, 20mm; 4154646 170-28-00 - biolox delta femoral head 28mm od, +0mm; 4430397 180-65-20 - alteon 6.5mm screw, 20mm; 4635261 186-01-50 - integrip cc, cluster 50mm.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, 10 DEG FACE, 36MM ID, GRP 2 CUP
• 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: 17398233
• MDR Text Key: 319838907
• Report Number: 1038671-2023-01782
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024886
• UDI-Public: 10885862024886
• 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: 04/30/2024

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: 05/04/2015
• Device Catalogue Number: 138-36-52
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2011
• 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
• Patient Age: 70 YR
• Patient Sex: Female