MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS; SEE H10

Catalog Number 130-32-52

Device Problem Naturally Worn (2988)

Patient Problem Implant Pain (4561)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: (b)(6): 164-01-11 - element-stem, collarless w/ha, std offset, sz 11; (b)(6): 122-65-25 - 6.5mm acetabular bone screw 25mm; (b)(6): 122-65-25 - 6.5mm acetabular bone screw 25mm; (b)(6): 170-32-00 - biolox delta femoral head 32mm od, +0mm; (b)(6): 180-01-52 - nv crown cup clstr hole 52mm group 2.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation that the patient had an initial right total hip arthroplasty on (b)(6) 2021 and then approximately 10 years, 9 months later experienced a revision surgery.Revision operative report of (b)(6) 2023-failed right tha (acetabular implants).Severe poly wear with soft tissue damage around the hip joint.Femoral stem was stable and well fixed ¿ therefore did not revise.Cup was easily removed ¿ it was not well fixed.The backside of the cup had no bone in-growth.There was extensive soft tissue debris throughout the kneed joint consistent with synovitis from a polyethylene reaction to the tissues.This was tiny, small balls of light brown synovium along with a ¿pseudo-capsule¿ of dense soft tissue rind.Examination of polyethylene ¿ excessive wear was present with signs of oxidation / yellow discoloration, pitting, cracking and delamination of the poly.Severe eccentric superior lateral poly wear.Revision right tha.Sterile dressing applied to the incision using sterile technique.Patient reversed from anesthesia and sent to pacu in stable condition.Hospital care days- admitted (b)(6) 2023 discharged (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No other information is available.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 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: kate jacobson ; 3523771140
• MDR Report Key: 17809827
• MDR Text Key: 324168835
• Report Number: 1038671-2023-02364
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022165
• UDI-Public: 10885862022165
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2017
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Date Device Manufactured: 07/23/2012
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female