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 Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

As reported, the patient had an initial tha on an unknown date.The patient was revised on (b)(6) 2024; reason unknown.No further information provided at this time.

Manufacturer Narrative

Section h10: (h3) a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.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 revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in an hhe including but not limited to use error, implant positioning, implant size selection, and patient factors, which led to polyethylene wear.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.Section h11: *the following sections have corrected information: (d1) brand name: nv gxl lnr, +5lat, 32mm g2-52/54mm cups.(d10) concomitant device(s): (b)(6), 180-01-54 - crown cup,cluster-hole gr.54.(h6) medical device problem code: 2988.

Event Description

It was reported that this 62 y/o female patient's left hip was revised approximately 5 years post op.As part of the follow-up care after hip prosthesis implantation on the left, inlay wear was observed in an asymmetrical manner.Head position diagnosed by the resident colleagues.The patient presented herself with the x-rays control.The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum and greater trochanter as a sign of premature inlay wear.This was possible when the inlay was changed on (b)(6), 2024 to a specially approved vitd-hardened one.Inlay (novation xle +5mm, lateralized liner, group 2, 36 mm i.D., ref 146-36-52, sn (b)(6)) can be verified.As part of the replacement operation, in addition to the inlay replacement, the solid cup integrity was determined as well as the curettage and filling of the cysts in the socket and in the greater trochanter using allogeneic cancellous bone and changing the prosthetic head.

• 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18677958
• MDR Text Key: 335027103
• Report Number: 1038671-2024-00186
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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