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 Code	Failure of Implant (1924)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this patient had a revision due to premature polyethylene wear and osteolysis.No additional information available.
Additional Manufacturer Narrative
Section b5: additional information received indicates that patient revision was performed on (b)(6)2022.Patient was revised with a competitors.The stem was retained.Patient is a male, 70 years old.Section d10: concomitant medical products: element-stem, collared w/ha, std offset, sz 11 (cat# 164-03-11 / serial# (b)(6)).Biolox delta femoral head 36mm od, +0mm (cat# 170-36-00 / serial# (b)(6)).Nv crown cup clstr hole 58mm group 3 (cat# 180-01-58 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt section d2: product code.
Additional Manufacturer Narrative
Section h10: (h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a lateralized liner and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13623208
• Report Number: 1038671-2022-00224
• Device Sequence Number: 12025305
• 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: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2022
• 2 Devices were Involved in the Event: 1 2

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: 01/27/2014
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 06/10/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/31/2022; 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male