MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 136-32-51

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation: (d10) concomitant device(s): 2229281 180-01-48 - crown cup,cluster-hole gr.48.

Event Description

The 84 y/o female patient had persistent pain on her left side in 2013 implanted hip prosthesis after a fall.There was a fracture of the acetabulum.The inlay wear was checked already diagnosed as part of the manufacturer's recall campaign.Suspects also emerged here.Changes noted in the acetabulum as a sign of possible osteolysis.The patient did not want to have the procedure done electively or for further diagnostics.A revision surgery was necessary due to the noted fracture.A revision hip cup with tab and iliac pin (competitor company) was implanted with filling of the osteolysis with allogeneic cancellous bone and changing the prosthetic head.Diagnosis that led to implantation: primary coxarthrosis m16.1 photos of the explants, will be sent upon receipt.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.After the examination (14 days of long-term incubation), these are sent back to us and then - a present one subject to the patient's consent.Surgical reports/x-rays are also available upon request.

Manufacturer Narrative

The revision reported was likely the result of the patient¿s reported fall which led to fracture of the acetabulum.The reported wear and osteolysis may have due to a combination of the risk factors specified in the hhe.However, this cannot be confirmed because the devices were not returned for evaluation and radiographs were not provided.Additionally, the components were implanted for over 10 years which may have contributed to the reported wear.

• Brand Name: NV GXL LNR, +5LAT, 32MM G1-48/50MM 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: 18310887
• MDR Text Key: 330284178
• Report Number: 1038671-2023-02962
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• 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: 02/26/2024

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 Expiration Date: 02/20/2017
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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: Female