MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 136-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: (b)(6) 180-01-54 - crown cup,cluster-hole gr.54.H7: z-2127-2021.

Event Description

It was reported that a male patient, who had an initial left hip prosthetic sockets from exactech implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 5 years 1 month post the initial procedure.As part of the manufacturer's recall campaign, the patient presented for a check-up.In the x-ray control there was a clear decentering of the prosthesis heads and unusually large osteolysis in both acetabula as a sign of premature inlay wear.This was confirmed when the inlay was changed on (b)(6), 2024, to a vitd-hardened, specially approved inlay (novation xle +5mm lateralized liner, group 2, 36 mm i.D., ref 146- 36-52, sn (b)(6)).As part of the replacement operation, after the inlay exchange, the determination of the solid cup integrity as well as the curettage and sealing of the cysts socket bearing using allogeneic cancellous bone and changing the prosthetic head.The explanted devices are unavailable for return.No further information provided.The patient was fitted with 2019 (left) and 2021 (right) hip prosthetic sockets from exactech on both sides implanted.The right side was changed in (b)(6) 2023, and was reported under 1038671-2024-00188.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19087363
• MDR Text Key: 339908215
• Report Number: 1038671-2024-00783
• 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
• Type of Report: Initial
• Report Date: 04/11/2024

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: 03/21/2023
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male