MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal team, approximately one month post initial tha, this female patient had a revision due to infection.No additional information available.
Additional Manufacturer Narrative
Concomitant medical products: cocr fem head 32mm +7 offset 12/14 (cat# 142-32-07 / serial# (b)(4) ) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
As reported by legal team, approximately one month post initial tha, this female patient had a revision due to infection.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: NV GXL LINER LIPPED 32MM ID, GROUP 1 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: 13771813
• Report Number: 1038671-2022-00259
• Device Sequence Number: 17169893
• Product Code: JDI
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 09/12/2022
• Device Model Number: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Device Catalogue Number: 132-32-51
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female