MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 130-32-51

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that this patient had a hip revision 3 years post op.The x-ray control showed decentration of the prosthesis head and the ct then showed unusually large osteolysis in the acetabulum as a sign of inlay wear.This was verified during the prosthesis revision on (b)(6) 2023.Due to the size of the osteolysis and the resulting lack of cup anchoring, the cup was changed to a revision hip cup with a tab and iliac peg.Furthermore, the cysts in the socket were curetted and sealed using allogeneic spongiosa and the prosthetic head was changed.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 6100361: 180-01-50 - crown cup,cluster-hole gr.50.

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 and osteolysis in (b)(4) is a combination of the risk factors specified in the hhe.However, this cannot be confirmed from the reported information.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 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: 18301215
• MDR Text Key: 330170033
• Report Number: 1038671-2023-02959
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121392
• 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: 02/20/2024

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: 10/21/2023
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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-1732-2022
• Patient Sequence Number: 1
• Patient Sex: Female