MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 136-32-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 5145289 180-01-56 - crown cup,cluster-hole gr.56.

Event Description

It was reported that 5.5 years post op this patient presented back to the surgeons office to get left hip prosthesis from 2018 checked.X-ray control showed a slight decentering of the prosthesis head and osteolysis in the acetabulum as signs of inlay wear.This was verified when the inlay was changed on (b)(6) 2023 to a vitd-hardened, specially approved inlay.As part of the replacement operation, in addition to the inlay replacement, the firm socket integrity was determined as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and the replacement of the prosthetic head.

Manufacturer Narrative

H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a lateralized liner.The most likely cause for the revision/monitoring reported due to early prosthesis wear and 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, +5 LAT 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 66 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18346422
• MDR Text Key: 330734457
• Report Number: 1038671-2023-03006
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862024299
• UDI-Public: 10885862024299
• 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: 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: 05/24/2022
• Device Catalogue Number: 136-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/18/2023
• 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: 05/26/2017
• 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-1729-2022
• Patient Sequence Number: 1
• Patient Sex: Male