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 02/22/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: 4179599 180-01-56 - crown cup, cluster-hole.H7: z-2117-2021.

Event Description

As part of the manufacturer's recall campaign, the patient presented for a new check-up.In the x-ray and ct control showed the well-known clear decentering of the prosthetic head and a clear increase in size of the known lysis in the acetabulum.That's why the revision and change took place on (b)(6) 2024 on a vite-hardened, specially approved inlay (novation xle neutral liner, group 3, 36 mm i.D., ref 140-36-53, sn: (b)(6).As part of the replacement operation, in addition to the inlay replacement, the firmness was determined cup integrity as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.

Manufacturer Narrative

H3: a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed from the reported information.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18927394
• MDR Text Key: 337944218
• Report Number: 1038671-2024-00547
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: 02/29/2020
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Male