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

Model Number 130-32-51

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 08/20/2020

Event Type  Injury  

Event Description

It was reported via legal documentation that this patient had a right total hip arthroplasty on (b)(6) 2014 and then approximately 6 years, 5 months later experienced a surgical revision on (b)(6) 2020.Patient revised to competitor¿s devices.Revision operative report of (b)(6) 2020-postoperative diagnosis(es): failed right hip replacement with a large amount of polyethylene wear and cystic invasion of the femur and the acetabulum.Indications for procedure: patient is a 71-year-old lady was noted to have significant polyethylene wear and pain.Mri showed a cavitary cyst forming around the hip.Procedure: there was some debris that had been channeling down around the proximal portion of the stem, but it was well fit, it was tamped on it several times to make sure the stem was well fixed.The surgeon was able to cut the cup out with virtually no bone loss in this case, they found a massive cavitary defect behind the cup, but the walls and the columns were still intact.They cleaned all the debris out of this and lavaged and packed it with bone graft.Components were trialed and then implant was completed.¿x-rays looked great¿.No apparent complication.Hospital care: admitted (b)(6) 2020/ discharged (b)(6) 2020.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.Concomitant medical product: 2960793 142-32-00 - cocr fem head 32mm +0 offset 12/14.2938073 164-13-12 - novation element ro s/o col sz 12.2938418 186-01-50 - integrip cc, cluster 50mm, g1.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.

Manufacturer Narrative

H6: investigation results - based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to prosthesis wear is a combination of the risk factors.However, this cannot be confirmed because the device was not available for evaluation and radiographs were not provided.

• 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 ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17276887
• MDR Text Key: 318565785
• Report Number: 1038671-2023-01578
• Device Sequence Number: 1
• Product Code: LZO
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 130-32-51
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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-1729-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female