MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 73 y/o patient had a right hip replacement on (b)(6) 2015.Approximately 7 years and 7 months after the initial procedure the patient had a right hip revision on (b)(6)2023 due to severe pain and osteolysis.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.14-feb-2023 op report: postoperative diagnosis: failed right hip replacement with extensive osteolysis.Sterile dressings were applied and the patient resident was taken to recovery room in satisfactory condition.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 180-65-15 - alteon 6.5mm screw, 15mm; (b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm; (b)(6), 101-05-20 - 3.2mm drill bit 20mm 1pk; (b)(6), 180-65-20 - alteon 6.5mm screw, 20mm; (b)(6), 164-03-11 - element-stem, collared w/ha, std offset, sz 11; (b)(6), 180-01-56 - nv crown cup clstr hole 56mm group 3.Pending investigation.
Additional 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 LNR, +5LAT, 36MM G3-56/58MM 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: matt collins ; 3523771140
• MDR Report Key: 17182169
• Report Number: 1038671-2023-01439
• Device Sequence Number: 12391710
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 11/16/2019
• Device Model Number: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Device Catalogue Number: 136-36-53
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male