MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	136-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: 2497306 164-13-11 - novation element ro s/o col sz 11.4430437 180-65-20 - alteon 6.5mm screw, 20mm.4502445 170-36-00 - biolox delta femoral head 36mm od, +0mm.4578636 101-05-20 - 3.2mm drill bit 20mm 1pk.4594202 186-01-52 - integrip cc, cluster 52mm, g2.
Event or Problem Description
It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2016 and then experienced a revision surgical procedure on (b)(6) 2022 approximately 5 years and 5 months after initial implant.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, type of investigation, investigation findings, investigation conclusions.The most likely cause for the reported revision due to prosthesis wear is a combination of the risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).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, +5LAT, 36MM G2-52/54MM CUPS
• Common Device Name: 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: matt collins
• MDR Report Key: 19132221
• Report Number: 1038671-2024-00907
• Device Sequence Number: 6853529
• Product Code: LZO
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 02/18/2019
• Device Catalogue Number: 136-36-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2014
• 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-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown