MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number SPECIFIC DEVICE NOT REPORTED

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Insufficient Information (4580)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

As reported via legal documentation the patient had a right hip replacement on (b)(6) 2009.Approximately 12 years and 8 months after the initial procedure the patient had a right hip revision on (b)(6) 2023 due to but not limited to polyethylene wear, instability, osteolysis, and component loosening.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

Additional information- a2, b1, b5, b6, b7, d1, d2a, d2b, d4 all, d10, g4 510k, h4, h6 health effect - clinical code & medical device problem code, h7, h8, & h9.D10-concomitants novation press-fit femoral stem, cobalt-chrome femoral head, 32 mm, novation crown cup cluster hole shell.These devices are used for treatment not diagnosis.No other information is available.Pending investigation.

Event Description

Additional information via legal-patient revised to exactech devices.Revision operative report of (b)(6) 2023-preliminary diagnosis- severe polyethylene wear of the right hip.Right revision total hip replacement of both components.Indications-75 yo patient presented with wear and early osteolysis and pain affecting the right hip.Radiographs revealed severe polyethylene wear over the recalled polyethylene liners.The patient was taken to the recovery area in stable condition with no complications noted about the surgery.Hospital care time: admitted on (b)(6)2023/discharged on (b)(6) 2023.No other information is available.

Manufacturer Narrative

H10.Updated/additional information ¿ 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 LNR, LIPPED 32MM ID GROUP 2 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17105811
• MDR Text Key: 316941698
• Report Number: 1038671-2023-01313
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10885862023315
• UDI-Public: 10885862023315
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2013
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 132-32-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2009
• 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-2133-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR