MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 5044279 170-36-03 - biolox delta femoral head 36mm od, +3.5mm 5224708 180-65-40 - alteon 6.5mm screw, 40mm 5135824 186-01-52 - integrip cc, cluster 52mm, g2 5040230 190-20-06 - alt ha s noclr std sz 6 5083877 101-05-30 - 3.2mm drill bit30mm 1pk.
Event or Problem Description
As reported, the 71 year old female patient had an initial left tha on (b)(6) 2018.The patient returned to the surgeon's office with a recalled hip liner and was revised on (b)(6) 2024 and underwent an acetabular poly liner swap and femoral head swap due to obvious early poly wear on x-ray, pain and dissatisfaction with their hip.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
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: 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 the hhe.However, this cannot be confirmed on the provided radiographs and the photo of the explanted devices do not appear to exhibit significant wear.

• Brand Name: NV GXL LINER LIPPED 36MM ID GROUP 2
• 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: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177901
• Report Number: 1038671-2024-00976
• Device Sequence Number: 7109731
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2022
• Device Catalogue Number: 132-36-52
• 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: 03/31/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 86 KG