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 11/16/2023

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: 5077591: 180-01-52 - crown cup,cluster-hole gr.52 h7: z-2127-2021.

Event Description

As part of the manufacturer's recall campaign, the patient came in to have the hip prosthesis implanted in 2017 checked.X-ray control showed a clear decentering of the prosthesis head and unusually large osteolysis in the acetabulum as signs of premature inlay wear.This was verified when the inlay was changed on (b)(6) 2023, to a vitd-hardened, specially approved inlay (novation xle extended coverage liner, group 2, 32mm i.D., ref 142-32-62, sn (b)(6).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.Diagnosis that led to implantation: primary coxarthrosis.

Manufacturer Narrative

H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: implanted with a lateralized liner.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified in the hhe.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.

• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18319002
• MDR Text Key: 330388035
• Report Number: 1038671-2023-02969
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: 03/06/2022
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention