MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 136-36-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/16/2024

Event Type  Injury  

Event Description

As part of the manufacturer's recall campaign, the patient presented himself for a check-up of the device implanted in 2013 left hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head a very large osteolysis in the acetabulum as a sign of inlay wear.There is an additional finding pronounced lumbar spine syndrome in polymyalgia rheumatica.During the revision surgery on (b)(6) 2023, he was able to radiological findings are confirmed.Because the socket was loose and osteolysis occurred due to the size then the complete socket change to a revision hip cup with tab and iliac pin.As part of the replacement operation, the changing the prosthetic head.

Manufacturer Narrative

Pending investigation.2491734 180-01-54 - crown cup,cluster-hole gr.54 h7: z-2128-2021.

Manufacturer Narrative

H3: the revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear and osteolysis after being implanted for 10+ years.It should also be noted that using both a lateralized liner and a group 2 acetabular liner with a 36mm femoral head creates a combination of the largest available head and the thinnest available acetabular liner (for group 2), which is a risk factor for early wear and lysis specified in the hhe.However, the reported wear and reason for revision cannot be confirmed as the devices were not available for evaluation and no pictures, radiographs, or medical records were provided at the time of this evaluation.

• Brand Name: NV GXL LNR, +5LAT, 36MM G2-52/54MM 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18650814
• MDR Text Key: 334656269
• Report Number: 1038671-2024-00158
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: 11/04/2017
• Device Catalogue Number: 136-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2012
• 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