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

Catalog Number 130-32-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(6) 170-32-03 - biolox delta femoral head 32mm od, +3.5mm.(b)(6) 180-01-52 - nv crown cup clstr hole 52mm group 2.(b)(6) 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 188-00-08 - wedge plasma s/o sz 8.Pending investigation.

Event Description

As reported via legal documentation the patient had a right hip replacement on (b)(6) 2015.Approximately 7 years and 11 months after the initial procedure the patient had a right hip revision on (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 additional information is available.Revision op report on (b)(6) 2023.Diagnosis: failed right hip.Findings: very stable reconstruction.Cup was easy to remove only one small portion had bone in growth (10% of the cup surface).Severe soft tissue reaction to osteolysis of the cup liner with subsequent bone loss.Femoral stem was stable and well fixed - therefore did not revise.There was extensive soft tissue debris throughout the knee joint consistent with a 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.I resected as much of this as safely possible.The total amount of soft tissue damage that required resection was ~6oz size.The polyethylene had excessive wear with signs of oxidation/yellow discoloration, pitting, cracking and delamination of the poly.Patient was sent to pacu in stable condition.

Manufacturer Narrative

The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: NV GXL LINR, NTRL, 32MM ID, GROUP 2 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
• Manufacturer Contact: matt collins
• MDR Report Key: 18517819
• MDR Text Key: 332925460
• Report Number: 1038671-2024-00091
• Device Sequence Number: 1
• Product Code: JDI
• 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: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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: 05/26/2020
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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: 64 YR
• Patient Sex: Female