MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-32-51

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

D2b-prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: 4617823 170-32-00 - biolox delta femoral head 32mm od, +0mm 4572532 186-01-48 - integrip cc, cluster 48mm, g1 3865832 188-00-02 - wedge plasma s/o sz 2 pending investigation.These devices are used for treatment not diagnosis.There is no other information available.

Event Description

It was reported via legal documentation that a patient had an initial total left hip replacement on or about (b)(6) 2017 and then approximately 5 years, 10 months later on or about (b)(6) 2022 the patient experienced a revision surgical procedure.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.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.

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 LINER NEUTRAL, 32MM ID GROUP 1 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: michael crader ; 3523771140
• MDR Report Key: 17541592
• MDR Text Key: 321079203
• Report Number: 1038671-2023-01936
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2019
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female