MAUDE Adverse Event Report: GXL LINER HIP IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

H10.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation from germany that a patient had a left hip arthroplasty on (b)(6) 2018 and is scheduled for a revision surgery on (b)(6) 2024.Inlay wear, left hip joint endoprosthesis, implantation (b)(6) 2018 it is noted that there is a clear decentering on the left side of the femoral head in a lateral-cranial direction with suspicion of lysis in the acetabulum.The additional ct scan of the pelvis confirmed this suspicion of inlay wear that had already been expressed conventionally by radiology when decentering the femoral heads in the artificial joints and also the evidence of large-volume cystic osteolysis at level the hip joint sockets.This is because the polyethylene coating is loose and leads to osteolysis.Diagnosis: inlay wear, left hip joint endoprosthesis, implantation (b)(6) 2018.Right hip joint endoprosthesis, implantation (b)(6) 2013.Case history: the patient presented as part of exactech's recall campaign for a check-up of the hip joints on both sides.He reports that he has slight discomfort on his left side, which feels like the femoral head hitting the edge of the socket early on.The right hip is free of symptoms.Finding: the patient comes into the examination room with a regular gait and (undressing).Mobility of the hip joints extension/flexion right 0-0-110 degrees, left 0-0-100 degrees, external/internal rotation right 40-0-30 degrees, left 30-0-20 degrees, no rotation pain, no compression pain, abduction on both sides 20 degrees.X-ray: pelvic overview and hips on both sides axially: on the right hip there is only a slight decentering of the femoral head in the socket, while on the left there is a clear lateral-cranial decentering of the hip head.Suspicion of lysis in the acetabulum.This is confirmed in the additional ct examination.Procedure: there was a detailed consultation and a demonstration of the images.It is recommended that the patient undergo an inlay and head replacement with filling of the lysis in the acetabulum.An operation date has already been arranged for (b)(6) 2024.The patient does not take anticoagulant medication regularly.Native ct of the pelvis from (b)(6) 2023 indication: mainly inlay wear recall exactech.Ms-helical ct (80 x 0.5 mm) with triplanar reconstruction in 3 mm slice thickness in the soft tissue and bone window.Conventional recording of the same day for comparison.Assessment: additional ct of the pelvis with confirmation of the conventional radiological examination, in particular the presence of an inlay fracture with decentration of the femoral heads in the artificial joints.Coarse cystic, impressive osteolysis at the level of the hip joint socket.Beyond that, no change in findings.There is no other information available.

• Brand Name: GXL LINER HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• MDR Report Key: 18715868
• MDR Text Key: 335526973
• Report Number: 1038671-2024-00232
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• 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: 73 YR
• Patient Sex: Male