MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number SPECIFIC DEVICE NOT REPORTED

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

Patient Problems Osteolysis (2377); Insufficient Information (4580)

Event Date 07/07/2022

Event Type  Injury  

Event Description

As reported via legal documentation the patient had a right hip replacement on (b)(6) 2015.Approximately 6 years and 9 months after the initial procedure the patient had a right hip revision on (b)(6) 2022.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

H6: investigation results - based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and osteolysis 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 early prosthesis wear and osteolysis is a combination of the risk factors specified in (b)(6).However, this cannot be confirmed from the reported information as devices, images, and radiographs were not provided.

Manufacturer Narrative

Health effect - clinical code & medical device problem code, h7, h8, & h9 d10.Concomitants: 142-32-93 - cocr fem head 32mm -3.5 offset 12/14, (b)(6), 164-13-08 - novation element ro s/o col sz 8, (b)(6), 180-65-20 - alteon 6.5mm screw, 20mm 4081160 186-01-48 - integrip cc, cluster 48mm, g1 (b)(6).Pending investigation.

Event Description

Revision operative report of (b)(6) 2022- patient was revised to exactech devices.Pre-procedure diagnosis: failed right total hip arthroplasty.Procedure(s): revision right total hip arthroplasty, acetabular liner, and femoral head ball with bone grafting of pelvis.Indication: this is a 78-year-old woman who previously underwent right anterior approach total hip arthroplasty.She subsequently underwent excision of heterotopic bone.Following that she developed radiographic signs of osteolysis and was noted to have a recall polyethylene liner.She has a minimal pain in her hip but has been having progressive lysis.Findings: well-fixed and positioned implants.Lytic lesion involving superior acetabulum with cortical perforation of posterior ilium, intact anterior and posterior columns, eccentric polyethylene wear with inflamed synovium.Impervious dressing was then placed, and the patient was positioned supine emerged from anesthesia in stable condition.No complications.No other information is available.

• Brand Name: NV GXL LINER NEUTRAL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17487240
• MDR Text Key: 320676959
• Report Number: 1038671-2023-01913
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2023
• 2 Devices were Involved in the Event: 1 2

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• 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: 12/12/2014
• 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: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female