MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 4525626 162-00-05 - neck preserving stem, std offset plasma sz 5.4767183 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.4769004 186-01-56 - integrip cc, cluster 56mm,g3.4775301 180-65-30 - alteon 6.5mm screw, 30mm.
Event or Problem Description
It was reported that approximately 87 months after a right total hip replacement procedure, the patient has experienced prosthesis wear.Initial surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.The serial number (b)(6) is confirmed to be a part of recall number: z-1729-2022 132-36-53 - nv gxl lnr, lipped, 36mm id, group 3 cups serial: (b)(6).510k: k070479.Udi: (b)(4) product code: jdi, lph, lwj, lzo, meh x-ray: no operative notes: no.Concomitant devices: 4525626 162-00-05 - neck preserving stem, std offset plasma sz 5.4767183 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.4769004 186-01-56 - integrip cc, cluster 56mm,g3.4775301 180-65-30 - alteon 6.5mm screw, 30mm.
Additional Manufacturer Narrative
H3: the most likely cause for the reported prosthesis wear is a combination of the risk factors specified in hhe.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: NV GXL LNR, LIPPED, 36MM 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 INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19706081
• Report Number: 1038671-2024-02332
• Device Sequence Number: 7526433
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 132-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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
• Patient Sex: Unknown