MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-32-52

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: alteon bone screw (180-65-20, sn (b)(6).Integrip cluster-hole shell (186-01-54, sn (b)(6).Novation element femoral stem (164-03-13, sn (b)(6).Cocr femoral head 32mm (142-32-03, sn (b)(6).H3.Initial investigation results before revision: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear, significant edge loading of the femoral head on the acetabular liner due to implant positioning.The most likely cause for monitoring for prosthesis wear is a combination of the risk factors 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); although there did not appear to be evidence of prosthesis wear at this time.

Event Description

As reported via legal documentation the patient had a right hip replacement on (b)(6) 2016.Approximately 6 years and 4 months after the initial procedure the patient had a right hip revision on (b)(6) 2022.Patient had been monitored by the surgeon for polyethylene wear.Revision operative report of 13 dec 2022 - preoperative diagnosis: failed right the due to poly wear, osteolysis and femoral loosening.Indication: right hip pain.Procedure: the femoral stem was loose, and scar tissue from the proximal femur was removed.There was moderate amount of metal stained tissue involving synovium, capsule and bone in the femur.A synovectomy was performed.No macroscopic evidence of infection.The previous 50mm acetabular cup was well fixed and position is considered appropriate (45 degrees of inclination and 20 degrees anteversion).The cup is tested provocatively and found to be very stable with excellent press-fit.There was poly wear, but decision was to revise the modular liner and cement a new vitamin-e enriched poly liner.The interval between the cup and liner is developed, the liner was removed.Retained the well-fixed cup and cement a constrained liner.Competitor devices were trailed and implanted.Dressings were applied and the patient is transferred to the recovery room in stable condition after reversal of anesthesia.Outpatient follow up 6 weeks post op, discharged home.No other information is available.

Manufacturer Narrative

H3: investigation results - the most likely underlying cause for the revision reported is femoral component loosening due to loss of mechanical and/or biologic fixation around the proximal femoral stem secondary to stress-shielding.The reported prosthesis wear could not be confirmed from the available information and the devices were not returned for evaluation.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: miguel sosa
• MDR Report Key: 18212890
• MDR Text Key: 329064954
• Report Number: 1038671-2023-02865
• 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,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male