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

Model Number NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: crown cup inlay,lat.+5 gr.3,32mm (cat# 136-32-53 / serial# (b)(6)).Crown cup,cluster-hole gr.56 (cat# 180-01-56 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the germany competent authorities and as part of the manufacturer's recall campaign, the patient went to have both hip prostheses checked (left implanted in 2019, right in 2021).The x-ray and ct check showed clear decentration both prosthetic heads with unusually large osteolysis in both acetabula as a sign of premature inlay wear.First, the right side was revised on (b)(6) 2023.The suspected diagnosis was confirmed and the inlay was replaced with a specially approved vitd-hardened one inlay (novation xle, neutral liner, group 3, 36 mm i.D., ref 140-36-53, sn (b)(6)).As part of the exchange operation, in addition to the inlay exchange, the solid cup integrity was determined as well as curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.The explants are currently with hospital and will be returned to the patient at their own request handed out.No further information provided.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18679010
• MDR Text Key: 335071565
• Report Number: 1038671-2024-00188
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/09/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2017
• 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 Outcome(s): Required Intervention
• Patient Sex: Male