MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; SEE H10

Catalog Number 130-32-51

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

Patient Problem Pain (1994)

Event Date 11/01/2017

Event Type  Injury  

Event Description

It was reported via legal documentation from ous, that a patient had an initial left hip arthroplasty for advanced arthrosis with gait disturbance and progressive hip pain in (b)(6) 2017, and then approximately 2 years later in (b)(6) 2019 had a revision surgical procedure.There is no diagnosis or reason provided for the hip revision.The patient underwent inpatient rehabilitation services for an unspecified length of time.It is stated that the patient suffers with pain and psychological impairments.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 other information is available.

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.D10.Concomitants: 4910796 130-32-51 - crown cup inlay pe, neut ø 48-50, ø 32.4909065 136-32-53 - crown cup inlay,lat.+5 gr.3,32mm.4782033 180-01-50 - crown cup,cluster-hole gr.50.4994805 180-01-58 - crown cup,cluster-hole gr.58.H3.Investigation results - the device nv gxl liner neutral, serial number 4910796 is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no other information available.

Manufacturer Narrative

Additional information: additional information requires new investigation.Pending investigation.Corrections.B3.Not explanted, date used is implant date.D6b.Not explanted.H3.Investigation results- new investigation required due to additional information.H6.Health effect - impact code & medical device problem code.

Event Description

Additional/corrected information- initial right hip arthroplasty for advanced arthrosis with gait disturbance and progressive hip pain on (b)(6) 2017, on an unspecified date.¿subsequent examinations confirmed the suspicion that the implant from your house had considerable wear, which is why the attending physicians determined that there was an immediate need for revision.¿ revision surgery for the right hip is reported to be scheduled for on (b)(6) 2024.There is no other patient demographic or medical history available.No other information is available.

Manufacturer Narrative

H10.H6.Investigation results - the most likely cause for the pending revision reported due to early prosthesis wear is a combination of the risk factors.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.However, this cannot be confirmed from the reported information.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17623349
• MDR Text Key: 321943469
• Report Number: 1038671-2023-02049
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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: 67 YR
• Patient Sex: Female