MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-40-53
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6) 186-01-56 - integrip cc, cluster 56mm,g3 (b)(6) 190-30-11 - alt ha s clr std sz 11 (b)(6) 170-40-03 - biolox delta femoral head 40mm 0d, +3.5mm.
Event or Problem Description
It was reported that this 76 y/o female patient's left hip was revised approximately 6 years 2 months post op.The patient had an original exactech tha on (b)(6) 2018.The patient returned to surgeons office with complaints of pain, and dissatisfaction with their hip.Upon examination, the patient has a recalled poly liner.The patient was scheduled for a revision total hip replacement possible poly liner and femoral head swap.The patient had revision surgery on (b)(6) 2024 and underwent a poly acetabular liner swap and femoral head swap.Patient was last known to be in stable condition following the event.Devices are not returning, sent to lab and legal hold at the hospital.
Additional Manufacturer Narrative
(h3) 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 is a combination of the risk factors specified in an hhe.The prosthesis wear was able to be confirmed from the provided radiograph/device images.*the following sections have corrected information: (h6) health effect clinical code, medical device problem.

• Brand Name: NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19296400
• Report Number: 1038671-2024-01191
• Device Sequence Number: 5665383
• Product Code: JDI
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2022
• Device Catalogue Number: 132-40-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 78 KG