MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 132-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right total hip replacement procedure on (b)(6) 2020 and then was revised approximately 3 years 8 months later on (b)(6) 2023.Patient was recommended elective revision surgery due to implant recall for prosthesis wear.During the removal of the original implant, gross findings of the right hip joint included moderate wearing of the articular bearing.There was mild lysis of the bone around the rim of the acetabulum around the proximal aspect of the femur after dissection of associated soft tissue with a rongeur and a curette.The patient was transferred to recovery in stable condition; no complications and procedure was tolerated well.The patient was revised to exactech devices.There is no other information provided/available.The mostly 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.However, this cannot be conclusively determined with the information provided.

Manufacturer Narrative

D10: concomitant devices: (b)(6) - flex drill m3.2x38 hd lenkbar.(b)(6) 186-01-54 - integrip cc, cluster 54mm, g2.(b)(6) 186-01-54 - integrip cc, cluster 54mm, g2.(b)(6) 170-32-03 - biolox delta femoral head 32mm od, +3.5mm.(b)(6) 188-00-08 - wedge plasma s/o sz 8.(b)(6) 170-32-00 - biolox delta femoral head 32mm od, +0mm.(b)(6) 188-01-07 - wedge plasma x/o sz.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.H7: recall number (z-1729-2022).H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: NV GXL LNR, LIPPED 32MM ID GROUP 2 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 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19154867
• MDR Text Key: 340799389
• Report Number: 1038671-2024-00930
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862023315
• UDI-Public: 10885862023315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2024

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 Catalogue Number: 132-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female