MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number 130-32-51

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

H10.D10.Concomitants: sn (b)(6) , cat# 142-32-00 - cocr fem head 32mm +0 offset 12/14.Sn (b)(6) , cat#164-13-09 - novation element ro s/o col sz 9.Sn (b)(6) , cat# 186-01-50 - integrip cc, cluster 50mm, g1.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2017 and the approximately 4 years, 4 months later experienced a revision surgery on (b)(6) 2021.Patient revised to competitor¿s devices, sans femoral head.Revision operative report of (b)(6) 2021- postoperative diagnosis: failed right tha due to poly wear and severe osteolysis.Severe acetabular bone loss (non-supportive posterior column, severe ilium, osteolysis).Patient has been having right hip pain since 2019 but aggravated it in (b)(6) 2021.Procedure: the femoral head was disimpacted from the trunnion, stem is well fixed and in appropriate position, it was retained.There was a significant amount of synovitis, the posterior aspect of the cup is completely unsupported by bone due to extensive posterior column osteolysis.A synovectomy was performed.There was no macroscopic evidence of infection.The scar capsule and synovial tissue were excised.There was macromotion between the gxl liner and the metal novation cup, suggesting damage of the locking mechanism, cup was removed.The medial wall was insufficient and there was massive uncontained and non­supportive osteolysis in the ischium and ilium, with severe bone loss deficiency (paprosky illa).Devices were trialed and then implanted.Dressings were applied and the patient transferred to the recovery room in stable condition after reversal of anesthesia.Hospital care-admitted (b)(6) 2021/discharged home (b)(6) 2021.Outpatient follow-up for 6 weeks post op.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 additional information is available.

Manufacturer Narrative

H6: investigation results - based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: significant edge loading of the femoral head on the acetabular liner and combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified in (b)(6).However, this cannot be confirmed from the reported information.

• Brand Name: NV GXL LINER NEUTRAL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• 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: 18097162
• MDR Text Key: 327698724
• Report Number: 1038671-2023-02723
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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-1732-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female