MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 130-32-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 3627610 180-01-58 - crown cup,cluster-hole gr.58.

Event Description

It was reported that this male patient was revised 8 years postop initial tha.The x-ray control showed a clear decentering of the prosthetic head, unusually large osteolysis in the acetabulum as a sign of inlay wear.This could happen to one.Inlay change on november 15, 2023 to a vitd-hardened, specially approved inlay.As part of the replacement operation, in addition to the inlay replacement, the solid cup integrity was determined as well as curettage and sealing the cysts in the socket using allogeneic spongiosa and changing the prosthetic head.

Manufacturer Narrative

Section h10: (h3) the prosthesis wear reported may have been due to a combination of the risk factors specified in an hhe such as use error, implant positioning, implant size selection, patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential), and/or surgical approach.However, this cannot be confirmed since the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18284459
• MDR Text Key: 329957259
• Report Number: 1038671-2023-02943
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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-1729-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male