MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; SEE H10

Catalog Number 136-32-52

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: crown cup,cluster-hole gr.52; cat# 180-01-52, sn (b)(6).These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation ous, that a patient had an initial right hip arthroplasty on (b)(6) 2016.The patient went to an inpatient rehabilitation at the rehabilitation center for orthopedic rehabilitation for an unknown amount of time.Examinations on (b)(6) 2023 showed an immediate need for revision.¿subsequent examinations confirmed the suspicion that the implant from your company showed considerable wear, which is why the attending physicians determined that an immediate revision was necessary.¿ since the end of 2019, the patient has been suffering from increasing back pain after standing and sitting for a long time and recently also with sudden pain symptoms in both hip joints (electric shocks).There is no other patient demographic or medical history available.No additional information is available.

Event Description

Additional information -the x-ray control showed a clear decentration of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.When changing the inlay on (b)(6) 2023, implanted a vitd-hardened, specially approved inlay.In addition to the inlay exchange, the operation was carried out to determine the solid integrity of the cup as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.Diagnosis that led to implantation: dysplasia-coxarthrosis m16.3.There is no other information available.

Manufacturer Narrative

H6: the most likely cause for the pending revision reported due to early prosthesis wear is a combination of the risk factors.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.However, this cannot be confirmed from the reported information.There is no other information.

• Brand Name: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: michael crader ; 3523771140
• MDR Report Key: 17663102
• MDR Text Key: 322418853
• Report Number: 1038671-2023-02118
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862024282
• UDI-Public: 10885862024282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2019
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female