MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS; SEE H10

Model Number SPECIFIC DEVICE NOT REPORTED

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

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

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

As reported via legal documentation the patient had a left hip replacement on (b)(6) 2015.Approximately 8 years and 2 months after the initial procedure the patient had a left hip replacement on (b)(6) 2023.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.

Event Description

Revision operative report on (b)(6) 2023-pre-operative long diagnosis: failed left total hip replacement secondary to poly wear.Evidence of osteolysis and poly wear involving mainly the acetabulum.The poly was noted to be wearing excessively.There was noted ostial lysis behind the screw holes as well as osteolysis over the superior rim of the acetabular component.Femoral head removed; there was slight trunnion metallosis.Bone scan negative for loosening.Revision left tha of acetabular component only.The patient tolerated the procedure well.No other information is provided.

Manufacturer Narrative

Additional information: h6 health effect - clinical code, medical device problem code.D2a.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: 3601984 120-65-20 - bone screw 6.5mm dia x 20mm long.2816164 160-31-16 - pf spline plasma w/ha ext offset sz 16.2419988 170-40-00 - biolox delta femoral 40mm od, +0m.3807630 186-01-58 - integrip cc, cluster 58mm.These devices are used for treatment not diagnosis.Pending investigation.No other 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 LIPPED 40MM ID, GROUP 3 CUPS
• Type of Device: SEE H10
• 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 ; 3523771140
• MDR Report Key: 17490561
• MDR Text Key: 320701102
• Report Number: 1038671-2023-01915
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 132-40-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male